๐ฌIn plain words
What the trial is, and whether it could suit you
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 dev
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Men and women with a BMI โฅ25 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 โฅ 7,0 mmol/L) and HbA1c โฅ 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-ฮฑ or PPAR-ฮณ agonists (fibrates), sulfonylureas, biguanides, ฮฑ-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs)
* Use of certain anticoagulants other than acetylsalicylic acid
* Use of antidepressants (stable use โฅ 3 months prior to and during study allowed)
* Use of statins (stable use โฅ 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