NCT04016350

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

July 5, 2019

Last Update Submit

July 9, 2019

Conditions

ExerciseInulin Propionate Ester

Keywords

Exercise,Inulin Propionate EsterGut hormonesBody weighFat oxidationOverweight women

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (6)

  • Body weight

    4 weeks

  • Body fat (%)

    4 weeks

  • Maximal oxygen consumption [Time Frame: 4 weeks]

    4 weeks

  • Peptide YY (PYY)

    4 weeks

  • Glucagon-like peptide-1 (GLP-1)

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Exercise training with placebo

Interventions

Exercise training with Inulin Propionate EsterBEHAVIORAL

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

Exercise Training with Inulin Propionate Ester
Exercise training with placeboBEHAVIORAL

Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks

Exercise Training with Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, sedentary and overweight females with BMI \>25 kg/m2 and stable body weight for two months prior to the study.

You may not qualify if:

  • Acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31790692DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exerciseinulin-propionate ester

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Douglas Morrison, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 11, 2019

Study Start

February 5, 2015

Primary Completion

March 10, 2017

Study Completion

June 11, 2017

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share