Effect of Fibre Products on Appetite and Weight
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|ClinicalTrials.gov Identifier: NCT00750438|
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : November 7, 2019
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Propionate ester Dietary Supplement: Inulin Dietary Supplement: Cellulose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.|
|Actual Study Start Date :||September 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||October 2012|
|Experimental: Propionate ester||
Dietary Supplement: Propionate ester
The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
|Placebo Comparator: Fermentable control||
Dietary Supplement: Inulin
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
|Placebo Comparator: Non fermentable control||
Dietary Supplement: Cellulose
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
- Appetite_Food Intake [ Time Frame: Baseline, 24 weeks ]The change in food intake following 24 weeks of supplementation
- Body Weight [ Time Frame: Baseline, 24 weeks ]Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
- Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight [ Time Frame: Baseline, 24 weeks ]Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
- Adipose Tissue Distribution - Intra-abdominal Adipose Tissue [ Time Frame: 24 weeks ]Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
- Insulin Sensitivity - HOMA IR [ Time Frame: 24 weeks ]The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
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): NCT00750438
|London, UK, United Kingdom, W12 0NN|
|Principal Investigator:||Gary Frost, PhD||Imperial College London|