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Clinical trial Recruiting at 1 site Interventional Ages 45 to 70

Sustainable diets to improve heart and metabolic health

Official title: PLANETDIET: Sustainable Diets and Cardiometabolic Health: a Multi-omics Approach in a Randomized Controlled Trial (RCT)

Run by University of Copenhagen · NCT07189676 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages45 Years to 70 Years
SexAll
Enrollment180 (estimated)
SponsorUniversity of Copenhagen
Academic / other
Locations1 site (Copenhagen, Copenhagen)
StatusRecruiting
StartedNovember 24, 2025
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedOctober 14, 2026
Trial IDNCT07189676 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Department of Nutrition, Exercise and Sports, University of Copenhagen. Rolighedsvej 26, DK-1958 Frederiksberg C.
    Copenhagen, Copenhagen, Denmark     Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.