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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03714646
Other study ID # NL63759.068.17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2018
Est. completion date May 10, 2019

Study information

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

Clinical Trial Summary

Based on our hypothesis that orally administered resistant starch and 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 May 10, 2019
Est. primary completion date May 10, 2019
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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
beta glucan and resistant starch
12g per day the day before the CID Resistant starch 7.5 g
Placebo
isocaloric maltodextrin before the CID
beta gluten
12 g beta gluten there day before the CID

Locations

Country Name City State
Netherlands Maastricht University Maastricht Limburg

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 (before a high-fat mixed meal)
Primary Plasma acetate concentrations (microM) four hours after a high fat mixed meal
Secondary Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) at baseline and four hours after a high fat mixed meal
Secondary fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) at baseline and four hours after a high fat mixed meal
Secondary carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands) at baseline and four hours after a high fat mixed meal
Secondary Circulating hormone concentrations (Insulin, GLP-1, PYY) at baseline and four hours after a high fat mixed meal
Secondary Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides) at baseline and four hours after a high fat mixed meal
Secondary Plasma glucose (mmol/L) at baseline and four hours after a high fat mixed meal
Secondary Free Fatty Acids (micromol/L) at baseline and four hours after a high fat mixed meal
Secondary Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK) at baseline and four hours after a high fat mixed meal
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