RCT to Describe the Effects of Colon Delivered Acetate, Propionate and Butyrate on Satiety and Glucose Homeostasis
PRO-ESTER
1 other identifier
interventional
23
1 country
1
Brief Summary
Obesity, with its associated co-morbidities, is a major public health challenge. It is estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is associated with increased risk of developing diabetes, cardiovascular disease, and certain cancers. The increasing epidemic of obesity has necessitated the study of the complex mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been shown to play an important role in regulating short-term food intake. Peripheral administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man. PYY, GLP-1 along with a host of other hormones are produced by the gut in response to nutrient availability in different regions of the gut and provide an exquisite mechanism of nutrient sensing in response to dietary intake. These hormones therefore represent potential targets in the development of novel anti-obesity treatments. A novel and attractive strategy to induce appetite regulation is the enrichment of foods with components that stimulate the release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free fatty acid receptors (FFAR) on colonic L cells. However, it is not known whether the three SCFA, acetate, butyrate and propionate, differentially affect appetite and glucose control. The aim of this study is to compare the effects of increased colonic delivery of acetate, butyrate and propionate on appetite and glucose control in overweight men in a randomised crossover study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jan 2015
1 active site
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
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 28, 2016
April 1, 2016
1.2 years
May 19, 2015
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Energy intake at ad libitum meal
Energy intake is measured at an ad libitum meal
8 hours
Secondary Outcomes (2)
Subjective appetite sensations
8 hours
Plasma glucose and insulin
2 hours
Other Outcomes (4)
Intestinal bacteria composition
24 hours
Lipids
8 hours
Appetite regulating gut hormones
8 hours
- +1 more other outcomes
Study Arms (3)
Inulin acetate ester
EXPERIMENTALInulin acetate ester, 10g/day for 30 days
Inulin propionate ester
EXPERIMENTALInulin propionate ester, 10g/day for 30 days
Inulin butyrate ester
EXPERIMENTALInulin butyrate ester, 10g/day for 30 days
Interventions
Inulin acetate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and oral glucose tolerance test (OGTT) on day 30.
Inulin propionate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and OGTT on day 30.
Inulin butyrate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and OGTT on day 30.
Eligibility Criteria
You may qualify if:
- Male and Female
- Healthy
- Overweight (BMI 25-40 kg/m2)
You may not qualify if:
- Weight change of \> 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease
- Kidney disease
- Liver disease
- Pancreatitis
- Use of any medication except contraceptive pill
- Peri-menopausal
- Pregnancy
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scottish Universities Environmental Research Centrelead
- NHS Greater Clyde and Glasgowcollaborator
- University of Glasgowcollaborator
Study Sites (1)
Glasgow Clinical Research Facility
Glasgow, Lanarkshire, G4 0SF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Morrison, PhD
Scottish Universitites Environmental Research Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 21, 2015
Study Start
January 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 28, 2016
Record last verified: 2016-04