Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a personalized nutrition plan designed to help prevent chronic diseases like type 2 diabetes and heart disease in people who are overweight or at risk. Researchers believe that by understanding each person's unique body type and how their metabolism works—what they call a "Metabotype"—they can create a diet that fits them better than general dietary guidelines. The goal is to help participants manage their blood sugar levels, reduce health risks, and improve their overall well-being.

To participate in this trial, individuals need to be between the ages of 18 and 65, have a body mass index (BMI) between 25 and 40, and have been stable in weight for at least three months. However, people with certain health conditions, like diagnosed diabetes, severe kidney or liver issues, or specific heart diseases, cannot join. Participants will receive a personalized diet plan and can expect regular follow-ups to monitor their progress. This study aims to develop more effective dietary strategies for those at increased risk of developing type 2 diabetes.

Gender

ALL

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