ExerciseIPENCT04016350
Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation
A study testing Exercise training with Inulin Propionate Ester in people with Exercise and Inulin Propionate Ester, run by University of Glasgow.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Inulin Propionate Ester
- What is being tested?
- Exercise training with Inulin Propionate Ester
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2015to 11 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, sedentary and overweight females with BMI >25 kg/m2 and stable body weight for two months prior to the study.
Who cannot join
- Acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.
About this study
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
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.
Read the 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.
- Conditions
- Exercise, Inulin Propionate Ester
- Being tested
- Exercise training with Inulin Propionate Ester, Exercise training with placebo
- Keywords
- Exercise,, Inulin Propionate Ester, Gut hormones, Body weigh, Fat oxidation, Overweight women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training with Inulin Propionate EsterBehavioural
Supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks.
Exercise training with placeboBehavioural
Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training with Inulin Propionate Ester | Experimental | Study participants underwent 4 week supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation at doses of 10g / day. Receives: Behavioral: Exercise training with Inulin Propionate Ester |
| Exercise Training with Placebo | Experimental | Study participants underwent 4 week supervised moderate intensity exercise training combined with cellulose as placebo at doses of 10g / day. Receives: Behavioral: Exercise training with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting fat oxidation
Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
Measured: 4 weeks
Resting carbohydrate oxidation
Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
Measured: 4 weeks
Metabolic rate
Changes in resting energy expenditure measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).
Measured: 4 weeks
Secondary outcomes (6)
Body weight
Changes in body weight measured by TANITA scales (TBF-300).
Measured: 4 weeks
Body fat (%)
Changes in body fat expressed as percentage (proportion of fat to the total body weight) measured by TANITA scales (TBF-300).
Measured: 4 weeks
Maximal oxygen consumption [Time Frame: 4 weeks]
Changes in maximal oxygen consumption (ml/kg/min) measured by Servomex Gas Analyser.
Measured: 4 weeks
Peptide YY (PYY)
Changes in plasma concentration of fasting and postprandial PYY measured using ELISA (Merc Millipore) kit.
Measured: 4 weeks
Glucagon-like peptide-1 (GLP-1)
Changes in plasma concentration of fasting and postprandial GLP-1 measured using ELISA (Merc Millipore) kit.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start5 Feb 2015
- Primary completion10 Mar 2017
- Study completion11 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Douglas Morrison, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016350
- Sponsor's protocol ID
- UGlasgow IPE
- Other IDs
- BB/L004259/1
- Acronym
- IPE
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malkova D, Polyviou T, Rizou E, Gerasimidis K, Chambers ES, Preston T, Tedford MC, Frost G, Morrison DJ. Moderate intensity exercise training combined with inulin-propionate ester supplementation increases whole body resting fat oxidation in overweight women. Metabolism. 2020 Mar;104:154043. doi: 10.1016/j.metabol.2019.154043. Epub 2019 Nov 29.
PubMed 31790692
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04016350
- Acronym / sponsor ID
- IPE / UGlasgow IPE
- Conditions
- Exercise, Inulin Propionate Ester
- Keywords
- Exercise,, Inulin Propionate Ester, Gut hormones, Body weigh, Fat oxidation, Overweight women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 11 Jun 2017 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Training with Inulin Propionate Ester | Experimental | Behavioral: Exercise training with Inulin Propionate EsterStudy participants underwent 4 week supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation at doses of 10g / day. |
| Exercise Training with Placebo | Experimental | Behavioral: Exercise training with placeboStudy participants underwent 4 week supervised moderate intensity exercise training combined with cellulose as placebo at doses of 10g / day. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, sedentary and overweight females with BMI >25 kg/m2 and stable body weight for two months prior to the study.
Key exclusion criteria (1 listed)
- Acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training with Inulin Propionate EsterSupervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks. | Behavioural | Exercise Training with Inulin Propionate Ester |
| Exercise training with placeboSupervised moderate intensity exercise training combined with placebo conducted for 4 weeks | Behavioural | Exercise Training with Placebo |
Primary outcome
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).
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).
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).
6 secondary outcomes
Body weight
Time frame: 4 weeks
Body fat (%)
Time frame: 4 weeks
Maximal oxygen consumption [Time Frame: 4 weeks]
Time frame: 4 weeks
Peptide YY (PYY)
Time frame: 4 weeks
Glucagon-like peptide-1 (GLP-1)
Time frame: 4 weeks
Height
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 31790692Malkova D, Polyviou T, Rizou E, Gerasimidis K, Chambers ES, Preston T, Tedford MC, Frost G, Morrison DJ. Moderate intensity exercise training combined with inulin-propionate ester supplementation increases whole body resting fat oxidation in overweight women. Metabolism. 2020 Mar;104:154043. doi: 10.1016/j.metabol.2019.154043. Epub 2019 Nov 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Morrison, PhD principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training with Inulin Propionate Ester in people with Exercise and Inulin Propionate Ester, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting fat oxidation (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.