Inulin and Acetate Production and Human Substrate Metabolism

Not Applicable

Completed

• Conditions: Obesity; Pre Diabetes
• Interventions: Dietary Supplement: Inulin and Resistant Starch; Dietary Supplement: Placebo; Dietary Supplement: Inulin

• Registration Number: NCT03711383
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-07-06
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inulin and Resistant Starch	Inulin and Resistant Starch	12 g inulin + 7.5 g resistant starch the day before CID
Placebo	Placebo	isocaloric maltodextrin the day before CIDs
Inulin	Inulin	12 g of inulin + isocaloric maltodextrin the day before CID

Primary Outcome Measures

Name	Time	Method
Plasma acetate concentrations (microM)	At baseline and up to four hours after a high-fat mixed meal of each CID

Secondary Outcome Measures

Name	Time	Method
Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating hormone concentrations (Insulin, GLP-1, PYY)	At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)	At baseline and up to four hours after a high-fat mixed meal of each CID
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)	At baseline and up to four hours after a high-fat mixed meal of each CID

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands