Trial Outcomes & Findings for Expression of Longevity Genes in Response to Extended Fasting (NCT NCT01059760)
NCT ID: NCT01059760
Last Updated: 2017-07-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 3 days
Results posted on
2017-07-17
Participant Flow
Participant milestones
| Measure |
Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
|
Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Expression of Longevity Genes in Response to Extended Fasting
Baseline characteristics by cohort
| Measure |
Fasting Day First
n=16 Participants
28±4 hours of water-only fasting followed by 28±4 hours fed
|
Fed Day First
n=14 Participants
28± 4 hours fed followed by 28± 4 hours of fasting
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.4 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Hemoglobin A1C
|
5.5 percentage
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.3 percentage
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.4 percentage
STANDARD_DEVIATION 0.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Glucose When Fasting and Fed
|
83.3 mg/dL
Standard Deviation 15.8
|
-8.0 mg/dL
Standard Deviation 15.4
|
5.9 mg/dL
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
|
0.32 ng/mL
Standard Deviation 0.47
|
1.54 ng/mL
Standard Deviation 2.63
|
-1.14 ng/mL
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Insulin When Fasting and Fed
|
23.6 mU/L
Standard Deviation 17.8
|
-19.0 mU/L
Standard Deviation 29.3
|
-1.6 mU/L
Standard Deviation 16.2
|
PRIMARY outcome
Timeframe: Baseline and 3 daysHOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Outcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
|
0.66 units on a scale
Standard Deviation 0.051
|
-0.35 units on a scale
Standard Deviation 0.53
|
-.02 units on a scale
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
|
1.77 ng/mL
Standard Deviation 0.79
|
-0.27 ng/mL
Standard Deviation 0.51
|
0.07 ng/mL
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Adiponectin When Fasting and Fed
|
0.34 ratio of high molecular to total
Standard Deviation 0.17
|
0.02 ratio of high molecular to total
Standard Deviation 0.25
|
-0.07 ratio of high molecular to total
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
|
190.3 pg/mL
Standard Deviation 261.4
|
-41.7 pg/mL
Standard Deviation 128.9
|
9.5 pg/mL
Standard Deviation 108.8
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
|
6.0 cells/mL
Standard Deviation 1.4
|
0.32 cells/mL
Standard Deviation 1.31
|
-0.12 cells/mL
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Hemoglobin When Fasting and Fed
|
14.3 g/dL
Standard Deviation 1.3
|
0.46 g/dL
Standard Deviation 0.37
|
-0.39 g/dL
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
|
4.7 cells x 10^6/mL
Standard Deviation 0.4
|
0.15 cells x 10^6/mL
Standard Deviation 0.13
|
-0.11 cells x 10^6/mL
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Hematocrit When Fasting and Fed
|
41.6 % of red blood cells to whole blood
Standard Deviation 3.6
|
1.3 % of red blood cells to whole blood
Standard Deviation 1.3
|
-1.1 % of red blood cells to whole blood
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Platelet Count When Fasting and Fed
|
253.5 cells x 10^3/mL
Standard Deviation 58.2
|
2.8 cells x 10^3/mL
Standard Deviation 16.3
|
0.9 cells x 10^3/mL
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
|
89.11 fL
Standard Deviation 3.56
|
-0.12 fL
Standard Deviation 0.68
|
-0.18 fL
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
|
30.66 pg
Standard Deviation 1.48
|
-0.01 pg
Standard Deviation 0.33
|
-0.07 pg
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
|
34.4 g/dL
Standard Deviation 0.5
|
0.02 g/dL
Standard Deviation 0.49
|
-0.01 g/dL
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
|
13.6 % of SD of MCV to mean MCV
Standard Deviation 0.82
|
-0.04 % of SD of MCV to mean MCV
Standard Deviation 0.32
|
-0.03 % of SD of MCV to mean MCV
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
|
8.17 fL
Standard Deviation 0.83
|
0.02 fL
Standard Deviation 0.49
|
0.03 fL
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Bicarbonate When Fasting and Fed
|
27.0 mmol/L
Standard Deviation 2.5
|
-1.4 mmol/L
Standard Deviation 1.7
|
0.9 mmol/L
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Sodium When Fasting and Fed
|
139.1 mmol/L
Standard Deviation 2.0
|
-1.4 mmol/L
Standard Deviation 2.1
|
0.7 mmol/L
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Chloride When Fasting and Fed
|
103.7 mmol/L
Standard Deviation 2.7
|
-1.3 mmol/L
Standard Deviation 2.0
|
0.9 mmol/L
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
|
16.0 mg/dL
Standard Deviation 3.7
|
-1.2 mg/dL
Standard Deviation 3.9
|
1.8 mg/dL
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Calcium When Fasting and Fed
|
9.4 mg/dL
Standard Deviation 0.3
|
0.18 mg/dL
Standard Deviation 0.34
|
-0.12 mg/dL
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Potassium When Fasting and Fed
|
4.29 mmol/L
Standard Deviation 0.28
|
-0.02 mmol/L
Standard Deviation 0.30
|
0.02 mmol/L
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Creatinine When Fasting and Fed
|
0.848 mg/dL
Standard Deviation 0.118
|
0.005 mg/dL
Standard Deviation 0.09
|
0.002 mg/dL
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
|
190.7 mg/dL
Standard Deviation 30.7
|
9.5 mg/dL
Standard Deviation 10.6
|
-4.8 mg/dL
Standard Deviation 11.0
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
|
103.8 mg/dL
Standard Deviation 33.8
|
23.1 mg/dL
Standard Deviation 35.1
|
-10.3 mg/dL
Standard Deviation 28.2
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
|
55.9 mg/dL
Standard Deviation 14.3
|
3.7 mg/dL
Standard Deviation 5.3
|
-1.0 mg/dL
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Triglycerides When Fasting and Fed
|
134.2 mg/dL
Standard Deviation 77.0
|
-52.4 mg/dL
Standard Deviation 55.5
|
11.2 mg/dL
Standard Deviation 38.1
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
|
3.63 ratio
Standard Deviation 1.15
|
-3.3 ratio
Standard Deviation 17.7
|
0.0 ratio
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Weight When Fasting and Fed
|
81.3 kg
Standard Deviation 25.0
|
-1.5 kg
Standard Deviation 0.9
|
0.5 kg
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Waist Circumference When Fasting and Fed
|
86.7 cm
Standard Deviation 16.7
|
-0.57 cm
Standard Deviation 1.4
|
0.54 cm
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
|
114.0 mmHg
Standard Deviation 13.6
|
-3.1 mmHg
Standard Deviation 8.4
|
1.0 mmHg
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
|
67.2 mmHg
Standard Deviation 8.8
|
1.7 mmHg
Standard Deviation 7.4
|
-1.2 mmHg
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Baseline and 3 daysOutcome measures
| Measure |
Baseline Value
n=30 Participants
|
Change While Fasting
n=30 Participants
|
Change When Fed
n=30 Participants
|
|---|---|---|---|
|
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
|
1.35 mg/L
Standard Error 0.96
|
0.00 mg/L
Standard Error 0.44
|
-0.10 mg/L
Standard Error 0.24
|
Adverse Events
Fasting Day First
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fed Day First
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fasting Day First
n=16 participants at risk
Includes those who fasted on the 1st day.
|
Fed Day First
n=14 participants at risk
Includes those who fasted on the 2nd day.
|
|---|---|---|
|
General disorders
Mild Headache
|
6.2%
1/16 • Number of events 1 • 3 days
|
7.1%
1/14 • Number of events 1 • 3 days
|
|
General disorders
Migraine
|
6.2%
1/16 • Number of events 1 • 3 days
|
0.00%
0/14 • 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place