Effect of Fibre Products on Appetite and Weight

Study Overview
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Brief Summary
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This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.

Detailed Description
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This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.

Official Title
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Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Propionate ester
* Dietary Supplement: Inulin
* Dietary Supplement: Cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteers aged between 21 and 65 years Exclusion Criteria: Weight change of more than 3kg in the preceding 2 months Current smokers Substance abuse Excess alcohol intake Pregnancy Diabetes Cardiovascular disease Cancer Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome Kidney disease Liver disease Pancreatitis Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propionate ester<br> | Dietary Supplement: Propionate ester<br>* The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks<br>|
| Placebo Comparator: Fermentable control<br> | Dietary Supplement: Inulin<br>* The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks<br>|
| Placebo Comparator: Non fermentable control<br> | Dietary Supplement: Cellulose<br>* The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite_Food Intake | The change in food intake following 24 weeks of supplementation | Baseline, 24 weeks | 
| Body Weight | Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing. | Baseline, 24 weeks | 
| Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight | Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing. | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipose Tissue Distribution - Intra-abdominal Adipose Tissue | Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content. | 24 weeks | 
| Insulin Sensitivity - HOMA IR | The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Short chain fatty acids, Appetite, Body weight, Insulin sensitivity, Propionate, Propionate ester