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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04016350
Other study ID # UGlasgow IPE
Secondary ID BB/L004259/1
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2015
Est. completion date June 11, 2017

Study information

Verified date July 2019
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is evidence to suggest that responsiveness to exercise training programmes can be expected to be influenced by changes in resting fat oxidation, an important factor in the aetiology of obesity. Our previous work has shown that oral supplementation with inulin propionate ester (IPE) reduces intra-abdominal fat and prevents weight gain and that oral propionate intake enhances resting fat oxidation. The effects of IPE combined with exercise training on resting fat oxidation and body fatness are unknown. The aim of this study was to investigate the impact of 4-weeks IPE supplementation, in combination with a moderate intensity exercise training programme, on whole body fat oxidation and on plasma GLP-1 and PYY.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 11, 2017
Est. primary completion date March 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise training with Inulin Propionate Ester
Supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks.
Exercise training with placebo
Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Glasgow

Outcome

Type Measure Description Time frame Safety issue
Primary Resting fat oxidation Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany). 4 weeks
Primary Resting carbohydrate oxidation Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany). 4 weeks
Primary Metabolic rate Changes in resting energy expenditure measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany). 4 weeks
Secondary Body weight Changes in body weight measured by TANITA scales (TBF-300). 4 weeks
Secondary Body fat (%) Changes in body fat expressed as percentage (proportion of fat to the total body weight) measured by TANITA scales (TBF-300). 4 weeks
Secondary Maximal oxygen consumption [Time Frame: 4 weeks] Changes in maximal oxygen consumption (ml/kg/min) measured by Servomex Gas Analyser. 4 weeks
Secondary Peptide YY (PYY) Changes in plasma concentration of fasting and postprandial PYY measured using ELISA (Merc Millipore) kit. 4 weeks
Secondary Glucagon-like peptide-1 (GLP-1) Changes in plasma concentration of fasting and postprandial GLP-1 measured using ELISA (Merc Millipore) kit. 4 weeks
Secondary Height 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
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