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Status:

NOT_YET_RECRUITING

Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

Lead Sponsor:

Maastricht University Medical Center

Collaborating Sponsors:

Wageningen University and Research

Health Holland

Conditions:

Obesity and Overweight

Pre-diabetic

Eligibility:

All Genders

40-75 years

Phase:

NA

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, adjus...

Detailed Description

Objective: Our study aims to identify unique Metabotypes among individuals with overweight and obesity and assess their response to a 1-year precision dietary macronutrient modulation. The objective ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT06923644

Start Date

April 1 2025

End Date

April 1 2027

Last Update

April 11 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

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

Maastricht, Netherlands, 6200MD

2

Wageningen University and Research, Division of Human Nutrition

Wageningen, Netherlands, 6700AA