Fiber and Insulin Sensitivity

Not Applicable

Completed

• Conditions: Insulin Resistance; Obesity
• Interventions: Dietary Supplement: Whole fiber product; Dietary Supplement: Placebo

• Registration Number: NCT04714944
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-20
• Study Start: 2021-02-05
• Status Verified: 2023-03
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whole fiber product	Whole fiber product	15 g for 2 weeks, followed by 30 g for 10 weeks
Placebo	Placebo	isocaloric placebo

Primary Outcome Measures

Name	Time	Method
Peripheral insulin sensitivity	Before and 12 week after the start of the intervention	The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp

Secondary Outcome Measures

Name	Time	Method
Substrate oxidation (indirect calorimetry)	Before and 12 week after the start of the intervention	The change in substrate oxidation as measured via ventilated hood system
Circulating inflammatory markers such as TNF	Before and 12 week after the start of the intervention	The change in inflammatory markers in peripheral blood
Energy expenditure (indirect calorimetry)	Before and 12 week after the start of the intervention	The change in energy expenditure as measured via ventilated hood system
Faecal microbiota composition and in vitro microbial activity testing	Before and 12 week after the start of the intervention	The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing
Circulating hormones such as insulin	Before and 12 week after the start of the intervention	The change in circulating hormones in peripheral blood
body weight	Before and 12 week after the start of the intervention	The change in body weight in kg
body composition	Before and 12 week after the start of the intervention	The change in body compostion as assessed using DEXA scans
liver fat content	Before and 12 week after the start of the intervention	The change in liver fat content as assessed by proton magnetic resonance spectrometry
hepatic and adipose tissue insulin sensitivity	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
Faecal and circulating SCFA	Before and 12 week after the start of the intervention	The change in faecal and circulating SCFA
In vitro microbial activity testing	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
Circulating metabolites such as glucose	Before and 12 week after the start of the intervention	The change in metabolites in peripheral blood

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands