Trial Outcomes & Findings for Investigating the Physiological Effects of Weight Loss on Male Fertility (NCT NCT03553927)
NCT ID: NCT03553927
Last Updated: 2024-11-07
Results Overview
The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-11-07
Participant Flow
Participant milestones
| Measure |
Low Energy Diet
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Study A (Men With a Normal Sperm Conc.)
STARTED
|
14
|
14
|
|
Study A (Men With a Normal Sperm Conc.)
COMPLETED
|
12
|
12
|
|
Study A (Men With a Normal Sperm Conc.)
NOT COMPLETED
|
2
|
2
|
|
Study B (Men With a Low Sperm Conc.)
STARTED
|
22
|
23
|
|
Study B (Men With a Low Sperm Conc.)
COMPLETED
|
20
|
23
|
|
Study B (Men With a Low Sperm Conc.)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Low Energy Diet
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Study A (Men With a Normal Sperm Conc.)
Withdrawal by Subject
|
2
|
2
|
|
Study B (Men With a Low Sperm Conc.)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
The overall number of baseline participants refers to the total number after combining the two sub-studies
Baseline characteristics by cohort
| Measure |
Low Energy Diet
n=32 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Study A (men with a normal sperm concentration) · <=18 years
|
0 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Categorical
Study A (men with a normal sperm concentration) · Between 18 and 65 years
|
12 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
12 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
24 Participants
n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Categorical
Study A (men with a normal sperm concentration) · >=65 years
|
0 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Categorical
Study B (men with a low sperm concentration) · <=18 years
|
0 Participants
n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Categorical
Study B (men with a low sperm concentration) · Between 18 and 65 years
|
20 Participants
n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
23 Participants
n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
43 Participants
n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Categorical
Study B (men with a low sperm concentration) · >=65 years
|
0 Participants
n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
0 Participants
n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Continuous
Study A (men with a normal sperm concentration)
|
40.2 Years
STANDARD_DEVIATION 9.6 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
39.4 Years
STANDARD_DEVIATION 6.4 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
39.8 Years
STANDARD_DEVIATION 8 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Age, Continuous
Study B (men with a low sperm concentration)
|
37.7 Years
STANDARD_DEVIATION 6.6 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
39.5 Years
STANDARD_DEVIATION 7.5 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
38.6 Years
STANDARD_DEVIATION 7.1 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Sex: Female, Male
Female
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=32 Participants
|
35 Participants
n=35 Participants
|
67 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=32 Participants
|
22 Participants
n=35 Participants
|
39 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=32 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=32 Participants
|
9 Participants
n=35 Participants
|
16 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Arab
|
6 Participants
n=32 Participants
|
1 Participants
n=35 Participants
|
7 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=67 Participants
|
|
Region of Enrollment
United Kingdom
|
32 participants
n=32 Participants
|
35 participants
n=35 Participants
|
67 participants
n=67 Participants
|
|
Weight
Study A (men with a normal sperm concentration)
|
109.5 Kilograms
STANDARD_DEVIATION 10.8 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
114.1 Kilograms
STANDARD_DEVIATION 11 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
112.6 Kilograms
STANDARD_DEVIATION 11.4 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Weight
Study B (men with a low sperm concentration)
|
116.8 Kilograms
STANDARD_DEVIATION 17.3 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
117 Kilograms
STANDARD_DEVIATION 21.9 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
116.9 Kilograms
STANDARD_DEVIATION 19.7 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Waist circumference
Study A (men with a normal sperm concentration)
|
117.3 Centimetres
STANDARD_DEVIATION 7.6 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
119.5 Centimetres
STANDARD_DEVIATION 9.1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
118.8 Centimetres
STANDARD_DEVIATION 8.4 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Waist circumference
Study B (men with a low sperm concentration)
|
123.4 Centimetres
STANDARD_DEVIATION 9.7 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
120.9 Centimetres
STANDARD_DEVIATION 12.9 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
122.1 Centimetres
STANDARD_DEVIATION 11.5 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Sperm concentration
Study A (men with a normal sperm concentration)
|
38.3 million sperms/mL
STANDARD_DEVIATION 15 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
54.2 million sperms/mL
STANDARD_DEVIATION 21.3 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
46.2 million sperms/mL
STANDARD_DEVIATION 19.8 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Sperm concentration
Study B (men with a low sperm concentration)
|
5.3 million sperms/mL
STANDARD_DEVIATION 3.4 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
9.8 million sperms/mL
STANDARD_DEVIATION 10.0 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
7.6 million sperms/mL
STANDARD_DEVIATION 7.9 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Semen volume
Study A (men with a normal sperm concentration)
|
3.3 ml
STANDARD_DEVIATION 1.4 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.9 ml
STANDARD_DEVIATION 1.1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.6 ml
STANDARD_DEVIATION 1.3 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Semen volume
Study B (men with a low sperm concentration)
|
3.7 ml
STANDARD_DEVIATION 1.8 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.3 ml
STANDARD_DEVIATION 1.4 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.4 ml
STANDARD_DEVIATION 1.6 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Progressive motility
Study A (men with a normal sperm concentration)
|
41 percentage of progressively motile sperm
STANDARD_DEVIATION 16 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
45 percentage of progressively motile sperm
STANDARD_DEVIATION 8 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
43 percentage of progressively motile sperm
STANDARD_DEVIATION 12 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
|
Progressive motility
Study B (men with a low sperm concentration)
|
28.7 percentage of progressively motile sperm
STANDARD_DEVIATION 13.2 • n=19 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
33.4 percentage of progressively motile sperm
STANDARD_DEVIATION 14.5 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
31.1 percentage of progressively motile sperm
STANDARD_DEVIATION 13.9 • n=39 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
|
|
Total motility
Study A (men with a normal sperm concentration)
|
48 percentage of sperm that is motile
STANDARD_DEVIATION 17 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
52 percentage of sperm that is motile
STANDARD_DEVIATION 8 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
50 percentage of sperm that is motile
STANDARD_DEVIATION 13 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
|
Total motility
Study B (men with a low sperm concentration)
|
35 percentage of sperm that is motile
STANDARD_DEVIATION 13.8 • n=19 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
40 percentage of sperm that is motile
STANDARD_DEVIATION 15.5 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
36 percentage of sperm that is motile
STANDARD_DEVIATION 15 • n=39 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
|
|
Body Mass Index (BMI)
Study A (men with a normal sperm concentration)
|
35.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
36.2 kg/m^2
STANDARD_DEVIATION 2.4 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
35.8 kg/m^2
STANDARD_DEVIATION 3.3 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Body Mass Index (BMI)
Study B (men with a low sperm concentration)
|
38 kg/m^2
STANDARD_DEVIATION 4 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
38 kg/m^2
STANDARD_DEVIATION 6.3 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
38 kg/m^2
STANDARD_DEVIATION 5.3 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
DNA Fragmentation Index
Study A (men with a normal sperm concentration)
|
11.9 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 13.1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
15.9 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 6.7 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
13.8 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 9.5 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
|
DNA Fragmentation Index
Study B (men with a low sperm concentration)
|
15.8 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 7.7 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
12.1 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 9.5 • n=17 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
13.6 percentage of sperm with fragmented DNA
STANDARD_DEVIATION 8.9 • n=29 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..
|
|
Testosterone
Study A (men with a normal sperm concentration)
|
12.7 nmol/l
STANDARD_DEVIATION 4.2 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
12.3 nmol/l
STANDARD_DEVIATION 2.5 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
12.5 nmol/l
STANDARD_DEVIATION 3.4 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Testosterone
Study B (men with a low sperm concentration)
|
12.6 nmol/l
STANDARD_DEVIATION 5.1 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
14.6 nmol/l
STANDARD_DEVIATION 5 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
13.4 nmol/l
STANDARD_DEVIATION 5.1 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Sex hormone-binding globulin (SHBG)
Study A (men with a normal sperm concentration)
|
21.8 nmol/l
STANDARD_DEVIATION 8.1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
25.2 nmol/l
STANDARD_DEVIATION 8.7 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
23.5 nmol/l
STANDARD_DEVIATION 8.4 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Sex hormone-binding globulin (SHBG)
Study B (men with a low sperm concentration)
|
21.4 nmol/l
STANDARD_DEVIATION 10.6 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
24.8 nmol/l
STANDARD_DEVIATION 9.6 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
23.2 nmol/l
STANDARD_DEVIATION 10.1 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Reactive oxygen species (ROS)
Study B (men with a low sperm concentration)
|
8.6 RLU/sec/million sperm
n=13 Participants • ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS. .
|
3.6 RLU/sec/million sperm
n=17 Participants • ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS. .
|
7.1 RLU/sec/million sperm
n=30 Participants • ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS. .
|
|
Morphology
Study A (men with a normal sperm concentration)
|
1.6 percentage of sperm of normal morphology
STANDARD_DEVIATION 1.3 • n=12 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
1.8 percentage of sperm of normal morphology
STANDARD_DEVIATION 1.4 • n=12 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
1.7 percentage of sperm of normal morphology
STANDARD_DEVIATION 1.3 • n=24 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
|
Morphology
Study B (men with a low sperm concentration)
|
0.4 percentage of sperm of normal morphology
STANDARD_DEVIATION 0.7 • n=17 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
1 percentage of sperm of normal morphology
STANDARD_DEVIATION 0.8 • n=20 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
0.7 percentage of sperm of normal morphology
STANDARD_DEVIATION 0.8 • n=37 Participants • Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.
|
|
Luteinizing Hormone (LH)
Study A (men with a normal sperm concentration)
|
3.2 IU/l
STANDARD_DEVIATION 1 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.5 IU/l
STANDARD_DEVIATION 1.7 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
3.3 IU/l
STANDARD_DEVIATION 1.4 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Luteinizing Hormone (LH)
Study B (men with a low sperm concentration)
|
3.7 IU/l
STANDARD_DEVIATION 0.9 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
4.3 IU/l
STANDARD_DEVIATION 1.5 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
4 IU/l
STANDARD_DEVIATION 1.2 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Follicle Stimulating Hormone (FSH)
Study A (men with a normal sperm concentration)
|
4.2 IU/l
STANDARD_DEVIATION 2.6 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
4.4 IU/l
STANDARD_DEVIATION 1.9 • n=12 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
4.3 IU/l
STANDARD_DEVIATION 2.8 • n=24 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
|
Follicle Stimulating Hormone (FSH)
Study B (men with a low sperm concentration)
|
5.6 IU/l
STANDARD_DEVIATION 2.9 • n=20 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
5 IU/l
STANDARD_DEVIATION 2.5 • n=23 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
5.3 IU/l
STANDARD_DEVIATION 2.7 • n=43 Participants • The overall number of baseline participants refers to the total number after combining the two sub-studies
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies
The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis
Outcome measures
| Measure |
Low Energy Diet
n=32 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Sperm Concentration
Study A (men with normal sperm concentration)
|
53.6 million sperms/mL
Standard Deviation 36.4
|
58.5 million sperms/mL
Standard Deviation 32.8
|
|
Sperm Concentration
Study B (men with low sperm concentration)
|
20.1 million sperms/mL
Standard Deviation 59.16
|
15 million sperms/mL
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.
Total motility refers to the percentage of sperm making any sort of movement.
Outcome measures
| Measure |
Low Energy Diet
n=29 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=33 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Total Motility
men with a normal sperm concentration
|
59.5 percentage of sperm that is motile
Standard Deviation 9.6
|
60.8 percentage of sperm that is motile
Standard Deviation 6.3
|
|
Total Motility
men with a low sperm concentration
|
48.9 percentage of sperm that is motile
Standard Deviation 12
|
45.4 percentage of sperm that is motile
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.
This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.
Outcome measures
| Measure |
Low Energy Diet
n=29 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=33 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Progressive Motility
Study A (men with a normal sperm concentration)
|
53.3 percentage of progressively motile sperm
Standard Deviation 10.4
|
53.9 percentage of progressively motile sperm
Standard Deviation 6.1
|
|
Progressive Motility
study B (men with a low sperm concentration)
|
42.8 percentage of progressively motile sperm
Standard Deviation 14.1
|
39.6 percentage of progressively motile sperm
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA fragmentation index.
Percentage of sperm with fragmented DNA
Outcome measures
| Measure |
Low Energy Diet
n=24 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=29 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
DNA Fragmentation Index (DFI)
Study A (men with a normal sperm concentration)
|
7.7 Percentage of sperm with fragmented DNA
Standard Deviation 8.7
|
19.8 Percentage of sperm with fragmented DNA
Standard Deviation 9.6
|
|
DNA Fragmentation Index (DFI)
study B (men with a low sperm concentration)
|
18.4 Percentage of sperm with fragmented DNA
Standard Deviation 11.7
|
11.2 Percentage of sperm with fragmented DNA
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.
Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.
Outcome measures
| Measure |
Low Energy Diet
n=31 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Testosterone
Study A (men with a normal sperm concentration)
|
13.6 nmol/l
Standard Deviation 5
|
12.4 nmol/l
Standard Deviation 2.8
|
|
Testosterone
study B (men with a low sperm concentration)
|
15.6 nmol/l
Standard Deviation 6.2
|
13.7 nmol/l
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.
SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form.
Outcome measures
| Measure |
Low Energy Diet
n=31 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Sex Hormone-Binding Globulin (SHBG)
(men with a normal sperm concentration)
|
30.2 nmol/l
Standard Deviation 12.6
|
26.4 nmol/l
Standard Deviation 7
|
|
Sex Hormone-Binding Globulin (SHBG)
study B (men with a low sperm concentration)
|
24.2 nmol/l
Standard Deviation 12.4
|
22.6 nmol/l
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS.
ROS is measured by oxidative colour change of luminol per second per million sperm.
Outcome measures
| Measure |
Low Energy Diet
n=14 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=19 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Reactive Oxygen Species (ROS)
|
13 RLU/sec/million sperm
Interval 3.0 to 39.1
|
5 RLU/sec/million sperm
Interval 0.9 to 37.4
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure morphology.
the percentage of sperm that appear normal when semen is viewed under a microscope
Outcome measures
| Measure |
Low Energy Diet
n=27 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=31 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Morphology
Study A (men with a normal sperm concentration)
|
1.2 percentage of sperm of normal morphology
Standard Deviation 1.1
|
1.9 percentage of sperm of normal morphology
Standard Deviation 1.7
|
|
Morphology
Study B (men with a low sperm concentration)
|
0.6 percentage of sperm of normal morphology
Standard Deviation 0.6
|
1.3 percentage of sperm of normal morphology
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.
LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.
Outcome measures
| Measure |
Low Energy Diet
n=31 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Luteinizing Hormone (LH)
Study A (men with a normal sperm concentration)
|
3.3 IU/l
Standard Deviation 1.4
|
2.8 IU/l
Standard Deviation 1.2
|
|
Luteinizing Hormone (LH)
Study B (men with a low sperm concentration)
|
3.5 IU/l
Standard Deviation 1.4
|
3.7 IU/l
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The overall number of participants analyzed refers to the total number after combining the two sub-studies. One participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.
FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.
Outcome measures
| Measure |
Low Energy Diet
n=31 Participants
Commercially available diet products
Low Energy Diet: Caloric restriction to achieve weight loss
|
NHS Advice on Healthy Eating
n=35 Participants
Dietary / lifestyle advice programme
NHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association
|
|---|---|---|
|
Follicle Stimulating Hormone (FSH)
Study A (men with a normal sperm concentration)
|
3.8 IU/l
Standard Deviation 2.1
|
4.5 IU/l
Standard Deviation 2.2
|
|
Follicle Stimulating Hormone (FSH)
Study B (men with a low sperm concentration)
|
5.4 IU/l
Standard Deviation 2.6
|
5 IU/l
Standard Deviation 2.4
|
Adverse Events
Low Energy Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NHS Advice on Healthy Eating
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place