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OpenTrials
Completed

NCT Number: NCT05378295

Personalized Fiber and Insulin Sensitivity

In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:

1. To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals; 2. To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 5229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 kg/m2)

Exclusion criteria

  • Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
  • Gastroenterological diseases or abdominal surgery;
  • Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
  • Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
  • Plans to lose weight or following of a hypocaloric diet;
  • Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
  • Intensive exercise training more than three hours a week;
  • Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
  • Regular use of laxation products;
  • Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
  • Follow a vegetarian diet.

Treatment and study plan

Fermentable oligosaccharide

Dietary Supplement

Supplementation period 12 weeks

Personalized fiber mixture

Dietary Supplement

Supplementation period 12 weeks

Primary outcomes

  1. Peripheral insulin sensitivity

    Time frame: Before and 12 week after the start of the intervention

    The change of peripheral insulin sensitivity (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary outcomes

  1. Energy expenditure (indirect calorimetry)

    Time frame: Before and 12 week after the start of the intervention

    The change in energy expenditure as measured via ventilated hood system

  2. Substrate oxidation (indirect calorimetry)

    Time frame: Before and 12 week after the start of the intervention

    The change in substrate oxidation as measured via ventilated hood system

  3. circulating SCFA

    Time frame: Before and 12 week after the start of the intervention

    The change in concentrations of circulating SCFA

  4. Faecal SCFA

    Time frame: Before and 12 week after the start of the intervention

    The change in concentrations of faecal SCFA

  5. Faecal microbiota composition and in vitro microbial activity testing

    Time frame: Before and 12 week after the start of the intervention

    The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene

  6. Circulating hormones such as insulin

    Time frame: Before and 12 week after the start of the intervention

    The change in concentrations of circulating hormones in peripheral blood

  7. Circulating metabolites such as glucose

    Time frame: Before and 12 week after the start of the intervention

    The change in concentrations of metabolites in peripheral blood

  8. body fat percentage

    Time frame: Before and 12 week after the start of the intervention

    The change in body fat percentage as assessed using DEXA scans

  9. fat mass

    Time frame: Before and 12 week after the start of the intervention

    The change in fat mass in kg as assessed using DEXA scans

  10. lean mass

    Time frame: Before and 12 week after the start of the intervention

    The change in lean mass in kg as assessed using DEXA scans

  11. visceral fat

    Time frame: Before and 12 week after the start of the intervention

    The change in visceral fat in gram as assessed using DEXA scans

  12. body weight

    Time frame: Before and 12 week after the start of the intervention

    The change in body weight in kg using a weight scale

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Personalized Microbial Substrates to Prevent Type 2 Diabetes

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Apr 23, 2024

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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