Personalized Fiber and Insulin Sensitivity

Type 2 Diabetes Clinical Trial

Official title:

Personalized Microbial Substrates to Prevent Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378295
• Other study ID #: NL76905.068.21
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Fermentable oligosaccharide
Supplementation period 12 weeks
• Personalized fiber mixture
Supplementation period 12 weeks

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Energy expenditure (indirect calorimetry)	The change in energy expenditure as measured via ventilated hood system	Before and 12 week after the start of the intervention
Secondary	Substrate oxidation (indirect calorimetry)	The change in substrate oxidation as measured via ventilated hood system	Before and 12 week after the start of the intervention
Secondary	circulating SCFA	The change in concentrations of circulating SCFA	Before and 12 week after the start of the intervention
Secondary	Faecal SCFA	The change in concentrations of faecal SCFA	Before and 12 week after the start of the intervention
Secondary	Faecal microbiota composition and in vitro microbial activity testing	The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene	Before and 12 week after the start of the intervention
Secondary	Circulating hormones such as insulin	The change in concentrations of circulating hormones in peripheral blood	Before and 12 week after the start of the intervention
Secondary	Circulating metabolites such as glucose	The change in concentrations of metabolites in peripheral blood	Before and 12 week after the start of the intervention
Secondary	body fat percentage	The change in body fat percentage as assessed using DEXA scans	Before and 12 week after the start of the intervention
Secondary	fat mass	The change in fat mass in kg as assessed using DEXA scans	Before and 12 week after the start of the intervention
Secondary	lean mass	The change in lean mass in kg as assessed using DEXA scans	Before and 12 week after the start of the intervention
Secondary	visceral fat	The change in visceral fat in gram as assessed using DEXA scans	Before and 12 week after the start of the intervention
Secondary	body weight	The change in body weight in kg using a weight scale	Before and 12 week after the start of the intervention