Fiber and Insulin Sensitivity

NCT04714944 | Completed DMC

• 1 other identifier: NL72483.068.20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Peripheral insulin sensitivity

  The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

  Before and 12 week after the start of the intervention

Secondary Outcomes (12)

• hepatic and adipose tissue insulin sensitivity

  Before and 12 week after the start of the intervention

• Energy expenditure (indirect calorimetry)

  Before and 12 week after the start of the intervention

• Substrate oxidation (indirect calorimetry)

  Before and 12 week after the start of the intervention

• Faecal and circulating SCFA

  Before and 12 week after the start of the intervention

• Faecal microbiota composition and in vitro microbial activity testing

  Before and 12 week after the start of the intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

isocaloric placebo

Dietary Supplement: Placebo

whole fiber product

EXPERIMENTAL

15 g for 2 weeks, followed by 30 g for 10 weeks

Dietary Supplement: Whole fiber product

Interventions

Placebo DIETARY_SUPPLEMENT

Supplementation period 12 weeks

Placebo

Whole fiber product DIETARY_SUPPLEMENT

Supplementation period 12 weeks

whole fiber product

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 \< 35 kg/m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 5229ER, Netherlands

Location

Related Publications (1)

• Omary L, Canfora EE, Puhlmann ML, Gavriilidou A, Rijnaarts I, Holst JJ, Op den Kamp-Bruls YMH, de Vos WM, Blaak EE. Intrinsic chicory root fibers modulate colonic microbial butyrate-producing pathways and improve insulin sensitivity in individuals with obesity. Cell Rep Med. 2025 Jul 15;6(7):102237. doi: 10.1016/j.xcrm.2025.102237.

  PMID: 40669445 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 20, 2021
• Study Start: February 5, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: February 12, 2024

Record last verified: 2023-03

Locations

NL (1)