Sustainable Diets and Cardiometabolic Health
PLANETDIET: Sustainable Diets and Cardiometabolic Health: a Multi-omics Approach in a Randomized Controlled Trial (RCT)
University of Copenhagen
180 participants
Nov 24, 2025
INTERVENTIONAL
Conditions
Summary
This study aims to investigate the effects of sustainable diets on traditional and novel cardiometabolic risk factors. The primary objective is: • To test the effects of a sustainable diet on traditional cardiometabolic risk factors, specifically, a metabolic health score. The secondary objectives are: * To test the effects of sustainable diets on blood lipids, inflammatory markers, glucose markers, and anthropometric and body composition markers. * To test the effect of sustainable diets on circulating metabolomic profiles. * To test the effects of sustainable diets on circulating proteomic profiles. Participants will receive dietary interventions of a sustainable health diet, namely the PHD diet (Planetary Health Diet), an ovo-lacto-vegetarian diet, or a habitual diet following general recommendations for a healthy diet without advice on consumption of animal products. The three-arm parallel RCT will involve adults (45-70 years old) at cardiovascular risk. The primary hypothesis is that targeted interventions to adopt sustainable diets will have beneficial effects on cardiometabolic biomarkers, metabolomic, and proteomic profiles, compared to the habitual diet in individuals at cardiovascular risk.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
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Interventions
It consists of a written document outlining the PHD diet recommendations. Participants will receive: 1) information about the PHD guidelines by EAT-Lancet (a high-quality plant-based diet with a low allowance of intake of eggs, dairy, chicken, and fish, but strictly avoiding red and processed meat) adapted to be nutritionally adequate and culturally accepted in Denmark, 2) a meal planner for their calorie demands (templates for 2000 kcal/day; 2500 kcal/day; and 3000 kcal/day), 3) guidance on alternatives for substituting meat when cooking at home or eating out, and 4) information on seasonal fruits and vegetables. The meal planner will specify the amounts of eggs, dairy, chicken, and fish that each participant should consume based on their total energy demands. The PHD dietary advice focuses on limiting certain food groups (without excluding them) based on their health and environmental impact.
It consists of a written document outlining the ovo-lacto-vegetarian diet guidelines. Participants will receive information to adhere to a stricter plant-based diet with an intake of eggs and dairy, but avoiding chicken, fish, and red and processed meat, and guidance on alternatives for substituting meat when cooking at home or eating out. Recommendations on food quantity or on consuming local and seasonal foods will not be given to pinpoint differences in the environmental aspect between interventions.
It consists of a written document outlining the general recommendations of a healthy diet (i.e. consumption of fruits and vegetables, decreasing the intake of sugar-sweetened beverages, etc.) without any specific advice on the consumption of animal products.
This component is designed to help participants adhere to the PHD through four individual and personalized dietary visits with a dietitian. Participants will also have access to a digital recipe collection in the study app. Recipes will be tagged by meal type and by season.
Food boxes will be sent to participants' homes. PHD food boxes will include seasonal and local fruits and vegetables, whole grain products, legumes, nuts, and dairy or milk alternatives. If allergies or intolerances are identified, the food boxes will be modified to maintain safety and dietary compliance.
Group visits will provide support through nutritional education, social interaction, and peer learning, all focused on the dietary behavior changes required by the intervention. PHD group visits will cover topics such as PHD principles, and the related environmental and health outcomes.
This component is designed to help participants adhere to the ovo-lacto-vegetarian through four individual and personalized dietary visits with a dietitian. Participants will also have access to a digital recipe collection in the study app. Recipes will be tagged by meal type.
Food boxes will be sent to participants' homes. Ovo-lacto-vegetarian food boxes will include fruits and vegetables, whole grains, legumes, nuts, soy-based products, eggs, and cheese. Local and seasonal aspects will not be taken into consideration. If allergies or intolerances are identified, the food boxes will be modified to maintain safety and dietary compliance.
Group visits will provide support through nutritional education, social interaction, and peer learning, all focused on the dietary behavior changes required by the intervention. Ovo-lacto-vegetarian group visits will cover topics such as plant-based eating and nutritional adequacy.
Participants will attend four short individual dietary visits with a dietitian, where they will review the recorded dietary data. Participants of the control group will not have access a recipe collection or meal planner.
Food boxes will be sent to participants' homes. Control food boxes will include fruits and vegetables, potato, nuts, cheese, animal protein products and canned food. Local and seasonal aspects will not be taken into consideration. If allergies or intolerances are identified, the food boxes will be modified to maintain safety.
Group visits will provide support through general health education, social interaction, and peer learning. Control group visits will cover topics such as the role and importance of controls in RCTs and general well-being.
Locations(1)
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NCT07189676