Precision nutrition to prevent diabetes and other metabolic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-centre, double-blind, randomized controlled parallel dietary intervention in 240 adults with BMI 25–40 kg/m2 and age 40–75 years. Participants are classified into one of three data-driven 'metabotypes' using a validated algorithm from baseline metabolic, body composition, and demographic data, then randomized to a metabotype-specific optimal macronutrient diet or a sub-optimal diet for one year. Primary outcomes include measures of glucose homeostasis, with secondary outcomes covering dietary adherence, body composition, tissue-specific insulin resistance markers, and psychosocial well-being. Metabotypes and the matching intervention are blinded to participants and researchers to reduce bias.

Why it matters

Who can join: the full rules

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

Where it's running

• Maastricht University Medical Center, Department of Human Biology, NUTRIM Institute of Nutrition and Translational Research in Metabolism
  Maastricht, Netherlands Recruiting
• Wageningen University and Research, Division of Human Nutrition
  Wageningen, Netherlands Recruiting

Study contacts

• Principal investigator: Ellen E Blaak, Prof. Dr. Ir. — Maastricht University Medical Center
• Study coordinator: Ellen E Blaak, Prof. Dr. Ir.
• Email: e.blaak@maastrichtuniversity.nl
• Phone: +31433881503

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.