adult-onset diabetes, obesity, overweight, Type 2 diabetes mellitus Diabetes or high blood sugar, severe overweight, overweight
Conditions
Interventions
Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimization, to either the Precision Nutrition (PN) group or the Control (CN
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men and women with overweight and obesity (age 40-75 years, BMI 25-40 kg/m2), without (Pre-)diagnosis of type 1 or type 2 diabetes mellitus. Stable body weight for at least 3 months (+/-3 kg).
Exclusion criteria
Exclusion criteria: - (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (e.g., 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., non-invasive 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 known to interfere with study outcomes (e.g., PPAR-a or PPAR-? agonists (fibrates), sulfonylureas, biguanides, a-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs) - For adipose tissue biopsy: 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 - 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 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) - Use of strong vitamins or other dietary supplements (e.g., pre- or probiotics) expected to interfere with the study outcomes - Metabotype classification is not possible - Pregnant or lactating women, or women who are planning to become pregnant - Inability to comply with the study diet - Participation in possibly interfering studies within the last 3 months - Inability to understand study information and/or communicate with staff - Unwillingness to be randomized 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extensive characterization will be done before, during, and after the intervention. Primary outcome measure is whole-body insulin sensitivity (Matsuda index) assessed by means of a 7-point oral glucose tolerance test (OGTT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include glycaemic variability, mean glucose levels, fasting lipid profiles, body composition, blood pressure, gene and protein expression of adipose tissue, microbial composition and functionality, metabolomics, physical activity, adherence to dietary recommendations, (mental) well-being, and quality of life. | — |
Countries
Netherlands
Contacts
Public ContactE.E. Blaak
Universiteit Maastricht
Outcome results
None listed