Obesity
Conditions
Interventions
Dietary Intervention: Participants will be randomly assigned to one of two
dietary groups for 4 weeks. The two groups will receive identical content and
variety in their fruit and vegetable packages
Sponsors
Dutch Research Council (NWO)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Healthy Volunteers: • Caucasian male/female • BMI: 18-25 kg/m² • Age: 18-45 years • Able to understand information and provide informed consent Metabolically Impaired Patients: • Caucasian male/female • Age: 18-45 years • BMI: 28-40 kg/m² treatment naïve • Metabolically impaired subjects with three of the following criteria: - Elevated Waist circumference: Waist circumference of >=102 cm (40 inches) in men or >=88 cm (35 inches) in women - High Fasting Glucose : A fasting glucose level of >=100 mg/dL (5.55 mmol/L) - High Fasting Insulin Level : A fasting insulin level >=25 µU/mL (or >16.7 pmol/L) - HOMA-IR score of >=2.5, indicating insulin resistance and impaired glucose metabolism • Able to understand information and provide informed consent
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: - Use of pre-, pro- or symbiotic. - Past/ currently following a vegan, strictly organic or vegetarian diet. - Currently following an organic lifestyle. - History of severe food allergies or intolerances that would render it unsafe for them to consume any of the fruits and vegetables provided. Exclusion will be determined on a case-by-case basis by the investigator. - Inability or unwillingness to collect feces. - Recent appearance of diarrhoea (>=3 stools/day), hematochezia. - Active infection during the study visit. - Use of systemic antibiotics 3 months prior to randomization. - Presence of overt type 1 diabetes mellitus (T1DM) and/or type 2 diabetes. - Use of medications for type 2 diabetes: metformin, statin, proton pump inhibitors (PPI), H2 blockers, pioglitazone, active GLP-1 receptor agonists (e.g., exenatide, liraglutide). - Use of methotrexate or amiodarone. - Prior or planned bariatric surgery, history of cholecystectomy. - History of cardiovascular disease: angina pectoris, myocardial infarction (MI), cerebrovascular accident (CVA), transient ischemic attack, peripheral artery disease, heart failure, pacemaker implantation. History of IBS (according to Rome IV criteria). - Having a severe disease of the digestive tract, such as celiac disease, Crohn*s disease, active ulcerative colitis or short bowel syndrome, functional chronic constipation. History of chronic, systemic autoimmune disorders with GI involvement, history of, or high risk for, GI cancer or polyposis. - Active or prior history of invasive malignancy (except for curatively treated in situ carcinomas [e.g., cervix] or non-melanoma skin cancer) unless a complete remission was achieved. - Prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count 5 units of alcohol daily on average in the past three months. - History of neurological/neurodegenerative disorders. - History of psychiatric conditions and/or eating disorders. - Any condition which, in the investigator*s opinion, might jeopardize participants* safety or compliance with the protocol. - Participation in another concomitant clinical trial. - Not residing in the Netherlands for the full 7-week duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to assess glucose metabolism using continuous glucose monitoring (CGM) technology and associated gut microbiome outputs by strain-level phenotyping. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include modifications in: • Plasma measures and inflammation markers • Gut microbiome composition (16S and WGS) • Fecal metagenomics, plant-gut taxonomic, functional annotations • Targeted metagenomics from plasma and feces: - Short-chain fatty acid (SCFA) concentrations - Tryptophan metabolism - Vitamins and other metabolites • Measurement of residues, including cadmium, synthetic fertilizer, and pesticide contaminants (in feces and urin), blood • QuinTron breath test • Blood pressure parametthese are the endpointsers • Body weight and composition through Bioelectrical Impedance Analysis (BIA). Calculated HOMA-IR score • Dietary intake will be evaluated through fecal plant DNA sequencing and food frequency questionnaire (FFQ). | — |
Countries
Netherlands
Contacts
Public ContactH. Herrema
Amsterdam UMC
Outcome results
None listed