Sustainable diets to improve heart and metabolic health
PLANETDIET: Sustainable Diets and Cardiometabolic Health: a Multi-omics Approach in a Randomized Controlled Trial (RCT)
This tests whether following a Planetary Health Diet or an ovo-lacto-vegetarian diet, compared with a general healthy diet, improves metabolic health in adults aged 45–70 who are at higher risk for heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen) |
| Trial ID | NCT07189676 on ClinicalTrials.gov |
What this trial studies
This randomized, three-arm trial will assign adults aged 45–70 with at least two metabolic risk factors to one of three dietary patterns: an adapted Planetary Health Diet (PHD), an ovo-lacto-vegetarian diet, or a control healthy diet following general recommendations. Trained dietitians will provide advice, behavioral support, and for the PHD arm food boxes to help participants follow the assigned pattern. The primary outcome is a composite metabolic health score, and secondary outcomes include blood lipids, inflammatory and glucose markers, anthropometry, body composition, and circulating metabolomic and proteomic profiles. The intervention is delivered at the University of Copenhagen with measurements taken at in-person visits and samples analyzed for traditional and novel biomarkers.
Who should consider this trial
Good fit: Adults aged 45–70 with at least two metabolic alterations (elevated waist circumference, high blood pressure or antihypertensive use, prediabetes, or abnormal blood lipids), who can attend in-person visits and understand Danish are ideal candidates.
Not a fit: People with recent serious illness or cancer, those outside the 45–70 age range, or those unable to commit to visits, follow dietary changes, or use required smartphones/computers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could show that sustainable, more plant-forward diets improve cardiometabolic risk factors and support healthier, environmentally friendly dietary recommendations.
How similar studies have performed: Some prior trials of plant-forward and vegetarian diets have shown metabolic benefits, but randomized evidence specifically testing the EAT-Lancet/Planetary Health Diet with multi-omic endpoints is limited, making this partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (males and females) between 45 and 70 years of age at the time of inclusion. * Participants must have at least two metabolic alterations: 1) Waist Circumference (WC) \>102 cm (males) or \>88 cm (females); 2) self-reported medication for blood pressure or blood pressure \>130/85 mmHg; 3) self-reported prediabetes or non-fasting plasma glucose 140-199 mg/dL (prediabetes); 4) self-reported lipid-lowering medication or diagnosis of impaired blood lipids (triglycerides: ≥ 150 mg/dL; and HDL: men: \< 40 mg/dL and women: \< 50 mg/dL). * Participants are not institutionalized, able to read and provide consent before participation, and willing to attend in-person visits at the study site. * Participants should have access to a smartphone and computer, or tablet and must be internet-literate. * Understand Danish both in writing and when spoken. Exclusion Criteria: * Participants with any serious illness or history of cancer within the past 5 years (except adequately treated localized basal cell skin cancer or in situ uterine cervical cancer). * Diagnosed with diabetes mellitus, CVD event (myocardial infarction, revascularization procedure, or stroke), or atrial fibrillation. * Participants with diagnosed psychiatric conditions or cognitive impairment. * Current smokers including all kinds of nicotine-containing products. * BMI \>35 kg/m2. * Known or suspected abuse of alcohol or recreational drugs. Regular alcohol consumption exceeding the Danish national guidelines (i.e., more than 10 standard drinks per week or more than 4 drinks on any single day) will be excluded. * Pregnancy or planning a pregnancy in the next year. * Not willing to consume chicken and fish or not willing to make dietary changes related to the intervention. * Participants with multiple food allergies that could hinder adherence to the intervention. * Any other issue that makes the project responsible (PI or medical responsible) doubt the eligibility of the volunteer.
Where this trial is running
Copenhagen, Copenhagen
- Department of Nutrition, Exercise and Sports, University of Copenhagen. Rolighedsvej 26, DK-1958 Frederiksberg C. — Copenhagen, Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Marta Guasch-Ferré, PhD
- Email: martaguasch@sund.ku.dk
- Phone: +45 93518439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.