NCT05378295

Brief Summary

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. 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
Last Updated

April 23, 2024

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 12, 2022

Last Update Submit

April 22, 2024

Conditions

Type 2 DiabetesInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Peripheral insulin sensitivity

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

    Before and 12 week after the start of the intervention

Secondary Outcomes (12)

  • 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

  • circulating SCFA

    Before and 12 week after the start of the intervention

  • Faecal 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

  • +7 more secondary outcomes

Study Arms (2)

isocaloric fermentable oligosaccaride

ACTIVE COMPARATOR

isocaloric fermentable oligosaccaride

Dietary Supplement: Fermentable oligosaccharide

Personalized fiber mixture

EXPERIMENTAL

12 g for 2 weeks, followed by 24 g for 10 weeks

Dietary Supplement: Personalized fiber mixture

Interventions

Fermentable oligosaccharideDIETARY_SUPPLEMENT

Supplementation period 12 weeks

isocaloric fermentable oligosaccaride
Personalized fiber mixtureDIETARY_SUPPLEMENT

Supplementation period 12 weeks

Personalized fiber mixture

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 5229ER, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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

May 12, 2022

First Posted

May 18, 2022

Study Start

November 5, 2021

Primary Completion

April 22, 2024

Study Completion

April 22, 2024

Last Updated

April 23, 2024

Record last verified: 2022-05

Locations

NL(1)