Clinical trial NCT03711383: Inulin and Acetate Production and Human Substrate Metabolism
Official title: The Effects of Inulin on Acetate Production and Human Substrate Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pre Diabetes
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 24
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:

To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.


Eligibility criteria: Inclusion Criteria:

* lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
* normoglycemic
* aged 30 - 65 years

OR

* overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
* pre-diabetes
* aged between 30 - 65 years.

Exclusion Criteria:

* diabetes mellitus
* gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
* lactose intolerance and other digestive disorders
* cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
* disease with a life expectancy shorter than 5 years
* Use of antibiotics 3 months prior inclusion
* Use of probiotics or prebiotics

Primary outcomes:
measure: Plasma acetate concentrations (microM)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary outcomes:
measure: Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
measure: Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
measure: Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
measure: Circulating hormone concentrations (Insulin, GLP-1, PYY)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
measure: Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
measure: Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)
timeFrame: At baseline and up to four hours after a high-fat mixed meal of each CID
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References:
citation: Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.