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Completed

NCT Number: NCT03711383

Inulin and Acetate Production and Human Substrate Metabolism

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin and Resistant Starch

Dietary Supplement

12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g

Inulin

Dietary Supplement

12g per inulin in combination with maltodextrin per day the day before the CID

Placebo

Dietary Supplement

isocaloric maltodextrin before test day

Primary outcomes

  1. Plasma acetate concentrations (microM)

    Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID

Secondary outcomes

  1. Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    Time frame: 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)

    Time frame: 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)

    Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID

  4. Circulating hormone concentrations (Insulin, GLP-1, PYY)

    Time frame: 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)

    Time frame: 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)

    Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effects of Inulin on Acetate Production and Human Substrate Metabolism

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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