Trial Outcomes & Findings for Application of New Technologies and Tools to Nutrition Research (NCT NCT01684917)

Results Overview

Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks. Energy intake was matched with estimated energy expenditure	Exercise, Control An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control overweight/ obese subjects with normal glucose metabolism for 12 weeks Energy intake was matched with estimated energy expenditure
Overall Study STARTED	11	7	13	5
Overall Study COMPLETED	11	7	13	5
Overall Study NOT COMPLETED	0	0	0	0

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	Exercise n=11 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet n=7 Participants overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control n=5 Participants overweight/ obese subjects with normal glucose metabolism for 12 weeks	Total n=36 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 1.7 • n=11 Participants	59 years STANDARD_DEVIATION 1.3 • n=7 Participants	50 years STANDARD_DEVIATION 2.1 • n=13 Participants	57 years STANDARD_DEVIATION 2.7 • n=5 Participants	55 years STANDARD_DEVIATION 2 • n=36 Participants
Sex: Female, Male Female	0 Participants n=11 Participants	4 Participants n=7 Participants	0 Participants n=13 Participants	2 Participants n=5 Participants	6 Participants n=36 Participants
Sex: Female, Male Male	11 Participants n=11 Participants	3 Participants n=7 Participants	13 Participants n=13 Participants	3 Participants n=5 Participants	30 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	11 participants n=11 Participants	7 participants n=7 Participants	13 participants n=13 Participants	5 participants n=5 Participants	36 participants n=36 Participants
BMI	28.9 kg/m^2 STANDARD_DEVIATION 2.5 • n=11 Participants	30.8 kg/m^2 STANDARD_DEVIATION 3.1 • n=7 Participants	23.5 kg/m^2 STANDARD_DEVIATION 2 • n=13 Participants	29.1 kg/m^2 STANDARD_DEVIATION 2 • n=5 Participants	28 kg/m^2 STANDARD_DEVIATION 2.3 • n=36 Participants
Fasting glucose	5.8 mmol/L STANDARD_DEVIATION 0.4 • n=11 Participants	5.0 mmol/L STANDARD_DEVIATION 0.6 • n=7 Participants	5.4 mmol/L STANDARD_DEVIATION 0.1 • n=13 Participants	4.6 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	5.2 mmol/L STANDARD_DEVIATION 0.4 • n=36 Participants
Total cholesterol	5.6 mg/dL STANDARD_DEVIATION 0.5 • n=11 Participants	5.6 mg/dL STANDARD_DEVIATION 1.2 • n=7 Participants	5.1 mg/dL STANDARD_DEVIATION 0.2 • n=13 Participants	4.9 mg/dL STANDARD_DEVIATION 0.3 • n=5 Participants	5.2 mg/dL STANDARD_DEVIATION 0.5 • n=36 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: No data available for diet and diet-control group

Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.

Outcome measures

Outcome measures
Measure	Diet overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control overweight/ obese subjects with normal glucose metabolism for 12 weeks	Exercise n=11 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
Insulin Sensitivity Baseline	—	7.6 mg/kg/min Standard Error 1.6	—	4.2 mg/kg/min Standard Error 1.8
Insulin Sensitivity 12 weeks	—	10.4 mg/kg/min Standard Error 2.6	—	5.4 mg/kg/min Standard Error 1.8

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.

Outcome measures

Outcome measures
Measure	Diet n=7 Participants overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control n=5 Participants overweight/ obese subjects with normal glucose metabolism for 12 weeks	Exercise n=11 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol Baseline	5.6 mg/dL Standard Error 1.2	5.1 mg/dL Standard Error 0.2	4.9 mg/dL Standard Error 0.3	5.6 mg/dL Standard Error 0.5
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol 12 weeks	4.9 mg/dL Standard Error 1.3	4.9 mg/dL Standard Error 0.1	5.1 mg/dL Standard Error 0.3	5.8 mg/dL Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Body Composition assessed by BMI

Outcome measures

Outcome measures
Measure	Diet n=7 Participants overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control n=5 Participants overweight/ obese subjects with normal glucose metabolism for 12 weeks	Exercise n=11 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
Body Composition Baseline	30.8 kg/m^2 Standard Error 3.1	23.5 kg/m^2 Standard Error 2	29.1 kg/m^2 Standard Error 2	28.9 kg/m^2 Standard Error 2.5
Body Composition 12 weeks	29.2 kg/m^2 Standard Error 3	23.5 kg/m^2 Standard Error 1.8	29.1 kg/m^2 Standard Error 2	28.6 kg/m^2 Standard Error 2.4

SECONDARY outcome

Timeframe: 12 weeks

Population: 1 missing data in diet group

Percentage Change in total adipose tissue assessed by MRI

Outcome measures

Outcome measures
Measure	Diet n=6 Participants overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control n=5 Participants overweight/ obese subjects with normal glucose metabolism for 12 weeks	Exercise n=7 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
Changes in Adipocyte Morphology	-8.9 percentage change Standard Error 3.3	-8.5 percentage change Standard Error 2.7	3.7 percentage change Standard Error 1.4	-10.9 percentage change Standard Error 5.1

SECONDARY outcome

Timeframe: 12 weeks

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Outcome measures
Measure	Diet n=7 Participants overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks	Exercise, Control n=13 Participants An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks	Diet, Control n=5 Participants overweight/ obese subjects with normal glucose metabolism for 12 weeks	Exercise n=11 Participants An overweight/dysglycemic group 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks
Body Weight Baseline	91.9 kg Standard Error 17.8	78.5 kg Standard Error 2.3	84.7 kg Standard Error 4.8	92.9 kg Standard Error 9
Body Weight 12 weeks	87.3 kg Standard Error 17.4	78.3 kg Standard Error 2.3	84.5 kg Standard Error 4.9	91.6 kg Standard Error 9.1

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise, Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diet, Control

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

Professor Gary Frost

Imperial College London

Phone: +44 (0)20 7594 0959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place