Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05378295
Other study ID # NL76905.068.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A