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RECRUITING

NCT06923644

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-04-23

Completion Date

2027-04

Last Updated

2026-01-20

Healthy Volunteers

Yes

Conditions

Obesity and Overweight Pre-diabetic Type 2 Diabetes Mellitus (T2DM)

Interventions

OTHER

Optimal 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.

OTHER

Sub-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.

Inclusion Criteria: * Men and women with a BMI ≥25 to \<40 kg/m2 * Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm. * Weight stability for at least 3 months (+/- 3 kg) Exclusion Criteria: Diseases * (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol/L) and HbA1c ≥ 6,5% (48 mmol/mol) * Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values) * Gastrointestinal diseases or abdominal surgery (allowed i.e.: appendectomy, cholecystectomy) * Food allergies, intolerances (including gluten/lactose intolerance) and/or eating disorders interfering with the study * Cardiovascular diseases (e.g., heart failure) or cancer (e.g., noninvasive skin cancer allowed) * High systolic blood pressure (untreated \>160/100 mmHg, drug-regulated \>140/90 mmHg) * Diseases affecting glucose and/or lipid metabolism (e.g., pheochromocytoma, Cushing's syndrome, acromegaly) * Diseases with a life expectation shorter than 5 years * Major mental disorders * Drug treated thyroid diseases (well substituted hypothyroidism is allowed inclusion) * Other physical/mental conditions that may interfere with study outcomes Medication * Medication known to interfere with study outcomes (e.g., PPAR-α or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs) * Use of certain anticoagulants other than acetylsalicylic acid * Use of antidepressants (stable use ≥ 3 months prior to and during study allowed) * Use of statins (stable use ≥ 3 months prior to and during study allowed) * Chronic corticosteroids treatment (\>7 consecutive days of treatment) * Use of antibiotics within 3 months prior to the study Lifestyle * Participation in regular sports activities (moderate-to-vigorous physical exercise \>4 hours per week) * Having a restricted dietary pattern interfering with the study diets (e.g., vegetarian, vegan, Atkins diet and/or other special diets) * Plans to lose or gain more than 5% body weight * Abuse of alcohol (alcohol consumption \>14 units/week) and/or drugs (cannabis included) * Not willing to limit alcohol consumption to 7 drinks per week * Regular smoking (including use of e-cigarettes and vapes) * Use of strong vitamins or other dietary supplements (e.g., pre- or probiotics) expected to interfere with the study outcomes Other * Metabotype classification is not possible * Pregnant or lactating women, or women who are planning to become pregnant * Inability to comply with the study diet * Blood donation within the last 3 months * Participation in possibly interfering studies within the last 3 months * Inability to understand study information and/or communicate with staff * Unwillingness to be randomised or sign informed consent * Unwillingness to save data for 15 years * Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or principal investigator

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