Inulin and Acetate Production and Human Substrate Metabolism

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03711383
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Pre Diabetes	Dietary Supplement: Inulin and Resistant Starch; Dietary Supplement: Inulin; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: The Effects of Inulin on Acetate Production and Human Substrate Metabolism
• Actual Study Start Date: Feb 20, 2018
• Actual Primary Completion Date: Nov 15, 2018
• Actual Study Completion Date: Nov 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo isocaloric maltodextrin the day before CIDs	Dietary Supplement: Placebo; isocaloric maltodextrin before test day
Active Comparator: Inulin 12 g of inulin + isocaloric maltodextrin the day before CID	Dietary Supplement: Inulin; 12g per inulin in combination with maltodextrin per day the day before the CID
Experimental: Inulin and Resistant Starch 12 g inulin + 7.5 g resistant starch the day before CID	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

Outcome Measures

Primary Outcome Measures

1. Plasma acetate concentrations (microM) [At baseline and up to four hours after a high-fat mixed meal of each CID]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. Circulating hormone concentrations (Insulin, GLP-1, PYY) [At baseline and up to four hours after a high-fat mixed meal of each CID]

5. Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides) [At baseline and up to four hours after a high-fat mixed meal of each CID]

6. Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK) [At baseline and up to four hours after a high-fat mixed meal of each CID]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Centre	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03711383
• Other Study ID Numbers: NL63754.068.17
• First Posted: Oct 18, 2018
• Last Update Posted: Jan 14, 2020
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prediabetic State

Study Results

No Results Posted as of Jan 14, 2020