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Inulin and Acetate Production and Human Substrate Metabolism

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Obesity
Pre Diabetes

Treatments

Dietary Supplement: Inulin
Dietary Supplement: Placebo
Dietary Supplement: Inulin and Resistant Starch

Study type

Interventional

Funder types

Other

Identifiers

NCT03711383
NL63754.068.17

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
isocaloric maltodextrin the day before CIDs
Treatment:
Dietary Supplement: Placebo
Inulin
Active Comparator group
Description:
12 g of inulin + isocaloric maltodextrin the day before CID
Treatment:
Dietary Supplement: Inulin
Inulin and Resistant Starch
Experimental group
Description:
12 g inulin + 7.5 g resistant starch the day before CID
Treatment:
Dietary Supplement: Inulin and Resistant Starch

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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