What is this study trying to find out about obesity and overweight?

This study evaluates whether a personalized diet based on unique metabolic profiles can better improve blood sugar control and reduce the risk of chronic metabolic diseases compared to general dietary guidelines. Researchers aim to see if tailoring nutrition to individual metabolism enhances dietary adherence and mental well-being for people with overweight or obesity. The study is sponsored by Maastricht University Medical Center.

Who may be eligible for this obesity and overweight clinical trial?

Adults aged 40 to 75 years with overweight or obesity (BMI 25-40 kg/m2) may be eligible. Participants must not have type 1 or type 2 diabetes and should have stable weight for at least 3 months. The study includes both men and women. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity and overweight clinical trial?

Study-related care, including the dietary intervention and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 75Years

All Genders

Healthy Volunteers

ID06923644

Precision Nutrition Study to Prevent Metabolic Diseases in Adults with Overweight and Obesity Tailored Diets Based on Metabolic Types to Improve Blood Sugar and Heart Health

Led by Maastricht University Medical Center · Updated on 2026-01-20

240

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how personalized diets, tailored to unique metabolic profiles called Metabotypes, can help people with overweight and obesity better manage blood sugar levels and reduce the risk of chronic metabolic diseases like type 2 diabetes and cardiovascular disease. The study aims to compare this precision nutrition approach with standard population-based dietary guidelines to see if it improves blood sugar control, dietary adherence, and mental well-being. This project will help develop targeted dietary strategies for individuals at higher risk of developing type 2 diabetes. The study is a double-blind, randomized controlled trial conducted at two centers involving 240 men and women aged 40 to 75 years with a BMI between 25 and 40 kgm2. Participants are classified into one of three Metabotype groups using a computer algorithm based on their body composition and glucose and insulin metabolism. They are randomly assigned to either a Precision Nutrition PN group, which receives a diet optimized for their specific Metabotype, or a Control CN group, which receives a diet designed for a different Metabotype. Both diets follow Dutch healthy dietary guidelines but differ in macronutrient composition and quality. The intervention lasts 12 months, with regular dietary consultations and meal plans provided. Participants will undergo extensive assessments before, during, and after the intervention, including a 7-point oral glucose tolerance test to measure insulin sensitivity Matsuda index, blood sugar levels, lipid profiles, body composition, blood pressure, gene and protein expression in fat tissue, gut microbiome analysis, metabolomics, physical activity, and mental health evaluations. Dietary adherence and quality of life are also monitored continuously. This comprehensive evaluation will help determine if the personalized dietary approach improves glucose regulation and overall cardiometabolic health over the 12-month period.

CONDITIONS

Brief Title

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Who Can Participate

Age: 40Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Men and women with a BMI 6525 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)

You will not qualify if you...

(Pre-)diagnosis of type 1 or type 2 diabetes mellitus (FPG 657.0 mmol/L) and HbA1c 656.5% (48 mmol/mol)
Renal or hepatic malfunctioning (pre-diagnosis or based on ALAT and creatinine values)
Gastrointestinal diseases or abdominal surgery (except appendectomy, cholecystectomy)
Food allergies, intolerances (including gluten/lactose intolerance) or eating disorders interfering with the study
Cardiovascular diseases (e.g., heart failure) or cancer (except noninvasive skin cancer)
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 life expectancy shorter than 5 years
Major mental disorders
Drug treated thyroid diseases (well substituted hypothyroidism allowed)
Other physical/mental conditions interfering with study outcomes
Medication interfering with study outcomes (e.g., PPAR agonists, sulfonylureas, biguanides, insulin, chronic NSAIDs)
Use of certain anticoagulants other than acetylsalicylic acid
Use of antidepressants or statins not stable for at least 3 months
Chronic corticosteroids treatment (>7 consecutive days)
Use of antibiotics within 3 months prior to the study
Regular participation in moderate-to-vigorous physical exercise >4 hours per week
Restricted dietary patterns interfering with study diets (e.g., vegetarian, vegan, Atkins)
Plans to lose or gain more than 5% body weight
Alcohol abuse (>14 units/week) or drug abuse (including cannabis)
Unwillingness to limit alcohol to 7 drinks per week
Regular smoking (including e-cigarettes and vapes)
Use of strong vitamins or supplements expected to interfere with outcomes
Metabotype classification not possible
Pregnant, lactating, or planning pregnancy
Inability to comply with the study diet
Blood donation within last 3 months
Participation in interfering studies within last 3 months
Inability to understand study information or communicate with staff
Unwillingness to be randomized or sign informed consent
Unwillingness to save data for 15 years
Deemed unsuitable for participation by study staff for any reason

Research Team

Ellen E Blaak, Prof. Dr. Ir.

Art Muijsenberg, MSc

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Precision Nutrition Study to Prevent Metabolic Diseases in Adults with Overweight and Obesity Tailored Diets Based on Metabolic Types to Improve Blood Sugar and Heart Health

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria