RecruitingNot ApplicableNCT06923644

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases


Sponsor

Maastricht University Medical Center

Enrollment

240 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation. The investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalised nutrition plan tailored to your specific metabolism (how your body handles food and blood sugar) to see if it can prevent long-term conditions like type 2 diabetes and heart disease. **You may be eligible if...** - You are a man or woman with a BMI between 25 and 40 (overweight or moderately obese) - Your weight has been stable (within about 3 kg) for at least 3 months - You fit one of the metabolic profiles the study is examining **You may NOT be eligible if...** - You already have type 2 diabetes (fasting blood sugar ≥7.0 mmol/L or HbA1c ≥6.5%) - You have kidney or liver problems, heart failure, or active cancer - You have a food allergy, gluten or lactose intolerance, or an eating disorder that would interfere with the diet - You have had certain gut surgeries (beyond appendix or gallbladder removal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROptimal Metabotype-specific diet

Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimisation, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a diet hypothesised to be optimal for their specific Metabotype. All participants will adhere to their assigned diets for 12 months. Each Metabotype-specific diet will align with the Dutch Healthy Dietary Guidelines, while varying in macronutrient composition and quality.

OTHERSub-optimal diet

Participants randomised to the Control Group (CN), will be randomly assigned one of the two diets optimised for a different Metabotype of the same sex. The assigned CN Group diet will always have a macronutrient content and quality that is different than their hypothesised optimal diet. All diets will align with the Dutch Healthy Dietary Guidelines.


Locations(2)

Maastricht University Medical Center, Department of Human Biology, NUTRIM Institute of Nutrition and Translational Research in Metabolism

Maastricht, Netherlands

Wageningen University and Research, Division of Human Nutrition

Wageningen, Netherlands

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NCT06923644


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