NCT06923644 Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 240 participants in total. It began in 2025-04-23 with a primary completion date of 2027-04.

Brief 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 Criteria

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

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