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OpenTrials
Completed

NCT Number: NCT04714944

Fiber and Insulin Sensitivity

Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.

The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.

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Key information

Age range

45 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: No

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

Inclusion criteria

Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 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.
  • Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
  • The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
  • Claustrophobia

Treatment and study plan

Placebo

Dietary Supplement

Supplementation period 12 weeks

Whole fiber product

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 as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary outcomes

  1. hepatic and adipose tissue insulin sensitivity

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

    The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

  2. 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

  3. 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

  4. Faecal and circulating SCFA

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

    The change in faecal and circulating 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 as assessed via 16s rRNA gene sequencing

  6. In vitro microbial activity testing

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

    The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon

  7. Circulating hormones such as insulin

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

    The change in circulating hormones in peripheral blood

  8. Circulating metabolites such as glucose

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

    The change in metabolites in peripheral blood

  9. Circulating inflammatory markers such as TNF

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

    The change in inflammatory markers in peripheral blood

  10. body weight

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

    The change in body weight in kg

  11. body composition

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

    The change in body compostion as assessed using DEXA scans

  12. liver fat content

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

    The change in liver fat content as assessed by proton magnetic resonance spectrometry

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Gut Microbial Substrate Switch to Improve Metabolic Health

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2021
Registry last updated
Feb 12, 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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