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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propionate ester | Experimental |
| |
| Fermentable control | Placebo Comparator |
| |
| Non fermentable control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propionate ester | Dietary Supplement | The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Frost, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | UK | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25500202 | Result | Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10. | |
| 27169834 |
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Non fermentable arm not conducted
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| ID | Title | Description |
|---|---|---|
| FG000 | Inulin-control | Participants received inulin |
| FG001 | Inulin-propionate Ester | Participants received inulin-propionate ester |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inulin-control | Participants received inulin |
| BG001 | Inulin-propionate Ester | Participants received inulin-propionate ester |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Appetite_Food Intake | The change in food intake following 24 weeks of supplementation | Posted | Mean | 95% Confidence Interval | kcal | Baseline, 24 weeks |
|
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inulin-control | Participants received inulin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost | Imperial College London | +44 (0)20 7594 0959 | g.frost@imperial.ac.uk |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Inulin | Dietary Supplement | The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks |
|
| Cellulose | Dietary Supplement | The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks. |
|
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
| 24 weeks |
| Derived |
| Byrne CS, Chambers ES, Alhabeeb H, Chhina N, Morrison DJ, Preston T, Tedford C, Fitzpatrick J, Irani C, Busza A, Garcia-Perez I, Fountana S, Holmes E, Goldstone AP, Frost GS. Increased colonic propionate reduces anticipatory reward responses in the human striatum to high-energy foods. Am J Clin Nutr. 2016 Jul;104(1):5-14. doi: 10.3945/ajcn.115.126706. Epub 2016 May 11. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Mean | Standard Deviation | mmol/mol |
|
|
|
|
| Primary | Body Weight | Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing. | Posted | Mean | Standard Error | kg | Baseline, 24 weeks |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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. | MRS data could not be collected in 17 subjects, due to metal implants (n=8) and claustrophobia (n=9). | Posted | Mean | Standard Error | percentage of total adipose tissue | 24 weeks |
|
|
|
|
| Secondary | Insulin Sensitivity - HOMA IR | The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. | Posted | Mean | Standard Deviation | percentage of Beta Cell Function | 24 weeks |
|
|
|
|
| 31 |
| 0 |
| 31 |
| 14 |
| 31 |
| EG001 | Inulin-propionate Ester | Participants received inulin-propionate ester | 0 | 29 | 0 | 29 | 5 | 29 |
| Bloating | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Heartburns | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Belching | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Superiority |
| Regression, Linear | 0.099 | Superiority |
| Superiority |
| Regression, Linear | 0.027 | Superiority |
| Superiority |
| Regression, Linear | 0.549 | Superiority |