Trial Outcomes & Findings for Dietary Carbohydrate Manipulation and Energy Balance: RCT (NCT NCT03574987)

Results Overview

24-hour physical activity energy expenditure (kJ/day or kcal/day)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

7 days (across 12 weeks) - Primary outcome at week 4

Results posted on

2024-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	CONTROL Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW SUG Diet consisting of 50% carbohydrate (\<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW CHO Diet consisting of \<8% carbohydrate (\<5% sugar), 15% protein, \>77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
Overall Study STARTED	20	18	22
Overall Study COMPLETED	13	16	16
Overall Study NOT COMPLETED	7	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CONTROL n=18 Participants Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW SUG n=17 Participants Diet consisting of 50% carbohydrate (\<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW CHO n=18 Participants Diet consisting of \<8% carbohydrate (\<5% sugar), 15% protein, \>77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	Total n=53 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 18 • n=18 Participants	32 years STANDARD_DEVIATION 16 • n=17 Participants	34 years STANDARD_DEVIATION 14 • n=18 Participants	35 years STANDARD_DEVIATION 16 • n=53 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	10 Participants n=17 Participants	9 Participants n=18 Participants	30 Participants n=53 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	7 Participants n=17 Participants	9 Participants n=18 Participants	23 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	18 participants n=18 Participants	17 participants n=17 Participants	18 participants n=18 Participants	53 participants n=53 Participants

PRIMARY outcome

Timeframe: 7 days (across 12 weeks) - Primary outcome at week 4

Population: Dropout and/or missing data (device malfunction) between weeks 4 and 12.

24-hour physical activity energy expenditure (kJ/day or kcal/day)

Outcome measures

Outcome measures
Measure	CONTROL n=17 Participants Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW SUG n=16 Participants Diet consisting of 50% carbohydrate (\<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW CHO n=16 Participants Diet consisting of \<8% carbohydrate (\<5% sugar), 15% protein, \>77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
Physical Activity Energy Expenditure (kJ/Day or kcal/Day) Week 12	1142 kcal/d Interval 959.0 to 1324.0	1077 kcal/d Interval 914.0 to 1240.0	1136 kcal/d Interval 960.0 to 1311.0
Physical Activity Energy Expenditure (kJ/Day or kcal/Day) Week 4	1229 kcal/d Interval 1066.0 to 1392.0	1096 kcal/d Interval 929.0 to 1263.0	1275 kcal/d Interval 1107.0 to 1442.0

SECONDARY outcome

Timeframe: 7 days (across 12 weeks)

Time spent in different physical activity intensities (MET categories) (minutes)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days (across 12 weeks)

Energy expended in different physical activity intensities (MET categories) (kJ or kcal)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Estimated using food diaries, 7 days each time concurrently measured with PAEE and 3 days per week for the rest of the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured weekly using electric scales

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Bone mineral density measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Bone mineral content measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Fat mass measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Fat-free mass measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Android fat mass measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Gynoid fat mass measured using dual x-ray absorptiometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Resting metabolic rate will be measured using indirect calorimetry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Substrate oxidation will be measured using indirect calorimetry both at rest and during exercise

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Waist and hip circumference will be measured using a tape measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured daily using pedometers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hours (across 12 weeks)

Assessment of blood glucose, insulin, triglycerides, non-esterified fatty acids, lactate, beta-hydroxybutyrate, leptin, fibroblast growth factor-21, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, appetite hormone concentrations (including PYY, GLP-1, ghrelin)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured using an automated sphygmomanometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Food preference ratings determined by bespoke computer software

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured by 0-100 mm visual analogue scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days (across 12 weeks)

Measured using research-grade freestyle libre glucose monitors. Measured pre-, during- and at the end of the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Expression of a panel of genes related to glucose metabolism in adipose biopsies using real-time polymerase chain reaction

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Expression of various proteins related to glucose metabolism in adipose biopsies via Western blot

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Expression of a panel of genes related to glucose metabolism in muscle biopsies using real-time polymerase chain reaction

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Expression of various proteins related to glucose metabolism in muscle biopsies via Western blot

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Glycogen concentrations measured from vastus lateralis muscle samples

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Faecal sample DNA and water will be used to determine taxonomic and functional diversity of microbes using transcriptomic techniques

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Will be measured using handheld sticks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Will be measured across trial days

Outcome measures

Outcome data not reported

Adverse Events

CONTROL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LOW SUG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LOW CHO

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CONTROL n=18 participants at risk Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW SUG n=17 participants at risk Diet consisting of 50% carbohydrate (\<5% sugar), 15% protein, 35% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated	LOW CHO n=18 participants at risk Diet consisting of \<8% carbohydrate (\<5% sugar), 15% protein, \>77% fat Diet: Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
Musculoskeletal and connective tissue disorders Sports injury	0.00% 0/18 • 12 weeks	0.00% 0/17 • 12 weeks	5.6% 1/18 • Number of events 1 • 12 weeks

Additional Information

Professor Javier Gonzalez

University of Bath

Phone: 0122538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place