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Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation (IPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016350
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Dalia Malkova, University of Glasgow

Brief 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.

Condition or disease Intervention/treatment Phase
Exercise Inulin Propionate Ester Behavioral: Exercise training with Inulin Propionate Ester Behavioral: Exercise training with placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomised study with parallel design. Study participants underwent 4 week supervised moderate intensity exercise training combined either with IPE or cellulose as placebo supplementation at doses of 10g/day. Measurements were done before and after intervention
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Moderate Intensity Exercise Training Combined With Inulin Propionate Ester Supplementation on Whole Body Resting Fat Oxidation and Body Weigh in Overweight Women
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : June 11, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 4 weeks ]
    Changes in body weight measured by TANITA scales (TBF-300).

  2. 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).

  3. 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. Peptide YY (PYY) [ Time Frame: 4 weeks ]
    Changes in plasma concentration of fasting and postprandial PYY measured using ELISA (Merc Millipore) kit.

  5. 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.

  6. 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.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016350


Sponsors and Collaborators
University of Glasgow
Investigators
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Principal Investigator: Douglas Morrison, PhD University of Glasgow
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Dalia Malkova, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT04016350    
Other Study ID Numbers: UGlasgow IPE
BB/L004259/1 ( Other Grant/Funding Number: BBSRC )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Dalia Malkova, University of Glasgow:
Exercise,
Inulin Propionate Ester
Gut hormones
Body weigh
Fat oxidation
Overweight women