Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT06923644

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

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

240

Participants Needed

2

Research Sites

101 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

W

Wageningen University and Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 or type 2 diabetes mellitus (FPG 65 7.0 mmol/L) and HbA1c 65 6.5% (48 mmol/mol)
  • Renal or hepatic malfunctioning based on ALAT and creatinine values
  • Gastrointestinal diseases or abdominal surgery except appendectomy or cholecystectomy
  • Food allergies, intolerances, or eating disorders interfering with the study
  • Cardiovascular diseases or cancer except noninvasive skin cancer
  • High untreated systolic blood pressure >160/100 mmHg or drug-regulated >140/90 mmHg
  • Diseases affecting glucose or lipid metabolism such as pheochromocytoma, Cushing's syndrome, acromegaly
  • Diseases with life expectancy shorter than 5 years
  • Major mental disorders
  • Drug treated thyroid diseases except well substituted hypothyroidism
  • Other physical or mental conditions interfering with study outcomes
  • Use of medications interfering with study outcomes including specific diabetes drugs and chronic NSAIDs
  • Use of certain anticoagulants other than acetylsalicylic acid
  • Use of antidepressants or statins unless stable for 3 months or more
  • Chronic corticosteroids treatment over 7 consecutive days
  • Use of antibiotics within 3 months prior to study
  • Regular sports activities with moderate-to-vigorous exercise over 4 hours per week
  • Restricted dietary patterns like vegetarian, vegan, Atkins, or other special diets
  • Plans to lose or gain more than 5% body weight
  • Alcohol abuse (>14 units/week) or drug abuse including cannabis
  • Unwilling to limit alcohol consumption to 7 drinks per week
  • Regular smoking including e-cigarettes and vapes
  • Use of strong vitamins or supplements expected to interfere with study outcomes
  • Metabotype classification not possible
  • Pregnant, lactating, or planning pregnancy
  • Inability to comply with 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 by research physician or principal investigator for any reason

AI-Screening

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Trial Site Locations

Total: 2 locations

1

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

Maastricht, Netherlands, 6200MD

Actively Recruiting

2

Wageningen University and Research, Division of Human Nutrition

Wageningen, Netherlands, 6700AA

Actively Recruiting

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Research Team

E

Ellen E Blaak, Prof. Dr. Ir.

CONTACT

A

Art Muijsenberg, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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