- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016350
Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation (IPE)
Impact of Moderate Intensity Exercise Training Combined With Inulin Propionate Ester Supplementation on Whole Body Resting Fat Oxidation and Body Weigh in Overweight Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants: Healthy overweight females with BMI >25 kg/m2 and 25-45 years of age were recruited through advertisements and word of mouth on the campus of the University of Glasgow or from other public places. Participants were required to be sedentary, non-smokers, with stable body weight for two months prior to the study enrollment, not pregnant, free of medication, nutritional supplementation or following any specific diet and with no antibiotic use for the past three months. Participants with chronic illness, eating disorders and history of gastrointestinal operations were excluded.
Study Design: This is a randomized study with a parallel design. Study participants underwent 4 week supervised moderate intensity exercise training combined either with IPE (EX/IPE) or cellulose as placebo (EX/Placebo) supplementation at doses of 10g / day. Supplements were provided as sachets containing white powder and participants were asked to consume one sachet per day with breakfast in a way convenient for each participant. Before the start of the study and at the end of the 4-week intervention, participants were asked to conduct a submaximal exercise test. Prior to the first and after the second submaximal exercise test, participants of both groups conducted a 7-hour experimental trial which involved collection of expired air and blood samples in fasted and postprandial states. Body weight and body composition were measured in the fasted state. Prior to the first 7-hour experimental trial, participants were asked to record their diet for 3 days and replicate this intake prior to the second 7-hour experimental trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy, sedentary and overweight females with BMI >25 kg/m2 and stable body weight for two months prior to the study.
Exclusion Criteria:
Acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Training with Inulin Propionate Ester
Study participants underwent 4 week supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation at doses of 10g / day.
|
Supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks.
|
Experimental: Exercise Training with Placebo
Study participants underwent 4 week supervised moderate intensity exercise training combined with cellulose as placebo at doses of 10g / day.
|
Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting fat oxidation
Time Frame: 4 weeks
|
Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
|
4 weeks
|
Resting carbohydrate oxidation
Time Frame: 4 weeks
|
Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
|
4 weeks
|
Metabolic rate
Time Frame: 4 weeks
|
Changes in resting energy expenditure measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: 4 weeks
|
Changes in body weight measured by TANITA scales (TBF-300).
|
4 weeks
|
Body fat (%)
Time Frame: 4 weeks
|
Changes in body fat expressed as percentage (proportion of fat to the total body weight) measured by TANITA scales (TBF-300).
|
4 weeks
|
Maximal oxygen consumption [Time Frame: 4 weeks]
Time Frame: 4 weeks
|
Changes in maximal oxygen consumption (ml/kg/min) measured by Servomex Gas Analyser.
|
4 weeks
|
Peptide YY (PYY)
Time Frame: 4 weeks
|
Changes in plasma concentration of fasting and postprandial PYY measured using ELISA (Merc Millipore) kit.
|
4 weeks
|
Glucagon-like peptide-1 (GLP-1)
Time Frame: 4 weeks
|
Changes in plasma concentration of fasting and postprandial GLP-1 measured using ELISA (Merc Millipore) kit.
|
4 weeks
|
Height
Time Frame: 4 weeks
|
Height (meters)measured by stadiometer, a vertical ruler with a sliding horizontal paddle which is adjusted to rest on the top of the head.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Douglas Morrison, PhD, University of Glasgow
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UGlasgow IPE
- BB/L004259/1 (Other Grant/Funding Number: BBSRC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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