Clinical trial for Obesity and Overweight
Official title Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases
ClinicalTrials.gov ID: NCT06923644
What this study is testing
- What it's testing
- The study will find out whether matching a diet to a person’s metabolic phenotype improves blood‑sugar control, heart‑risk factors, and how well people stick to the plan compared with standard dietary advice.
- Who it's for
- Adults who are overweight or obese and have pre‑diabetes or early type 2 diabetes.
- What's involved
- Participants will receive a diet plan created from a computer model of their metabolism, attend counseling visits, and undergo blood tests and other health measurements.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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)
See the full eligibility 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)
- 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...
- 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 assigned by chance 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
The study team makes the final eligibility decision.
Where it is enrolling
- Maastricht, Netherlands
- Wageningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Maastricht, Netherlands; Wageningen, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.