Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems.
Walter Willett, Johan Rockström, Brent Loken...
https://pubmed.ncbi.nlm.nih.gov/30660336Actively Recruiting
Phase Not Applicable
Age: 45Years - 70Years
All Genders
Healthy Volunteers
ID07189676
PLANETDIET: Sustainable Diets and Cardiometabolic Health Using a Multi-omics Approach in a Randomized Controlled Trial
Led by University of Copenhagen · Updated on 2025-12-24
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Copenhagen
Lead Sponsor
N
Novo Nordisk Foundation (NNF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of sustainable diets on traditional and new heart and metabolic health risk factors in adults aged 45 to 70 years who are at risk for cardiovascular disease. The study focuses on comparing the Planetary Health Diet (PHD), an ovo-lacto-vegetarian diet, and a habitual diet to see how these diets influence a metabolic health score and various blood markers related to heart and metabolic health. This randomized controlled trial aims to address gaps in knowledge about sustainable diets and their impact on health and environmental outcomes. Participants will be randomly assigned to one of three groups: the PHD diet group, which follows a plant-based diet with limited eggs, dairy, chicken, and fish but avoids red and processed meat; the ovo-lacto-vegetarian diet group, which excludes chicken, fish, and red meat but includes eggs and dairy; or a control group that continues their usual diet with general healthy eating advice. Each group receives dietary advice, behavioral support through individual visits with dietitians, food boxes containing diet-specific foods, and group visits for education and peer support. The study lasts six months, including an information meeting, multiple visits for assessments, and group sessions. During the study, participants will provide blood, urine, and fecal samples at several time points for analysis of metabolic, inflammatory, and body composition markers. They will wear continuous glucose monitors for 10 days at the start and end of the study. A study app will support participants with dietary materials, meal planners, recipes, and questionnaires. Researchers will measure changes in metabolic health scores and related biomarkers at baseline, 3 months, and 6 months to understand how sustainable diets affect cardiometabolic health.
CONDITIONS
Brief Title
Sustainable Diets and Cardiometabolic Health
Who Can Participate
Age: 45Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults (males and females) between 45 and 70 years of age at the time of inclusion.
- Must have at least two metabolic alterations: large waist circumference (>102 cm for males or >88 cm for females), high blood pressure or medication for it, prediabetes or elevated blood sugar, or abnormal blood lipids or medication for it.
- Not institutionalized and able to read and provide consent.
- Willing to attend in-person visits at the study site.
- Must have access to a smartphone and computer or tablet and be internet-literate.
- Understand Danish both in writing and spoken form.
You will not qualify if you...
- Serious illness or history of cancer within the past 5 years (except treated localized basal cell skin cancer or in situ uterine cervical cancer).
- Diagnosed diabetes mellitus, cardiovascular event, or atrial fibrillation.
- Diagnosed psychiatric conditions or cognitive impairment.
- Current smokers or users of any nicotine products.
- Body mass index over 35 kg/m2.
- Known or suspected abuse of alcohol or recreational drugs; regular alcohol consumption exceeding national guidelines.
- Pregnancy or planning pregnancy within the next year.
- Unwilling to consume chicken and fish or to make dietary changes.
- Multiple food allergies that hinder diet adherence.
- Any other condition that raises eligibility concerns by the medical responsible investigator.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Enrollment and Baseline
Duration - 1 day
Participants attend the baseline visit where they receive dietary advice based on their assigned group, collect baseline biosamples, and receive the first food box. They also begin wearing a continuous glucose monitor (CGM) for 10 days.
1 baseline visit (in-person)
Intervention
Duration - 6 months
Participants follow their assigned dietary advice with behavioral support through individual dietitian visits, group visits, and receive food boxes at specified intervals. Biosamples are collected at 1 month and 3 months. Continuous support is provided via a study app.
Individual dietary visits (4 times), group visits (2 times), and food box deliveries at baseline, 1 month, and 3 months
Follow-up and Final Assessment
Duration - 1 day
At 6 months, participants attend the final visit for outcome assessments, including biosample collection and CGM monitoring for 10 days. This concludes the trial participation.
1 final visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Nutrition, Exercise and Sports, University of Copenhagen. Rolighedsvej 26, DK-1958 Frederiksberg C.
Copenhagen, Copenhagen, Denmark, 1958
Actively Recruiting
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Research Team
M
Marta Guasch-Ferré, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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