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Status:

COMPLETED

Fiber and Insulin Sensitivity

Lead Sponsor:

Maastricht University Medical Center

Conditions:

Obesity

Insulin Resistance

Eligibility:

All Genders

45-70 years

Phase:

NA

Brief Summary

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 c...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 5 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 29 2023

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT04714944

    Start Date

    February 5 2021

    End Date

    March 29 2023

    Last Update

    February 12 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Maastricht University

    Maastricht, Limburg, Netherlands, 5229ER