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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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