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NCT Number: NCT02009670

Inulin,SCFA Production and Metabolic Response

In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6229ER, Netherlands

About this study

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overweight, obese men

Exclusion criteria

  • athletes
  • diabetes mellitus

Treatment and study plan

13C inulin

Dietary Supplement

Oral 13C inulin

Placebo

Other

Oral maltodextrin

Primary outcomes

  1. Fat oxidation, energy expenditure

    Time frame: 1 study day for each administration

    Fat oxidation and energy expenditure are measured after inulin ingestion

Secondary outcomes

  1. Hormones that influence substrate and energy metabolism

    Time frame: 1 study day for each administration

    Insulin, GLP-1, PYY will be measured in plasma after inulin ingestion

  2. Circulating metabolites

    Time frame: 1 study day for each administration

    Glucose, FFA, TG will be measured in plasma after inulin ingestion

  3. Appetite VAS scoring

    Time frame: 1 study day for each administration

    Visual Analogue Scale for hunger and appetite are completed after inulin ingestion

  4. SCFAs

    Time frame: 1 study day for each administration

    SCFA content (acetate, butyrate and propionate, unlabeled and 13C-labeled) are measured after inulin ingestion in plasma, faeces

  5. Breath sampling 13CO2

    Time frame: 1 study day for each administration

    In breath samples 13CO2 will be measured after inulin ingestion

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

SCFA Production and Their Metabolic Effects After Inulin Ingestion

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Nov 25, 2015

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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