Inulin and Acetate Production and Human Substrate Metabolism

Obesity Clinical Trial

Official title:

The Effects of Inulin on Acetate Production and Human Substrate Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711383
• Other study ID #: NL63754.068.17
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: October 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Inulin and Resistant Starch
12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g
• Inulin
12g per inulin in combination with maltodextrin per day the day before the CID
• Placebo
isocaloric maltodextrin before test day

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma acetate concentrations (microM)		At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary	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
Secondary	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
Secondary	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
Secondary	Circulating hormone concentrations (Insulin, GLP-1, PYY)		At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary	Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)		At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary	Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)		At baseline and up to four hours after a high-fat mixed meal of each CID