Status:
RECRUITING
Sustainable Diets and Cardiometabolic Health
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Novo Nordisk Foundation (NNF)
Danish Heart Foundation
Conditions:
Cardiometabolic Diseases
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief 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 tradit...
Detailed Description
Background: To promote sustainable diets for planetary and human health, the EAT-Lancet Commission called for a global dietary transformation by 2050, advocating a dietary pattern shift to align food ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07189676
Start Date
November 24 2025
End Date
April 1 2027
Last Update
December 24 2025
Active Locations (1)
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1
Department of Nutrition, Exercise and Sports, University of Copenhagen. Rolighedsvej 26, DK-1958 Frederiksberg C.
Copenhagen, Copenhagen, Denmark, 1958