Actively Recruiting

Phase Not Applicable
Age: 45Years - 70Years
All Genders
Healthy Volunteers
NCT07189676

Sustainable Diets and Cardiometabolic Health

Led by University of Copenhagen · Updated on 2025-12-24

180

Participants Needed

1

Research Sites

70 weeks

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

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.

CONDITIONS

Official Title

Sustainable Diets and Cardiometabolic Health

Who Can Participate

Age: 45Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults between 45 and 70 years old
  • Have at least two metabolic issues: large waist circumference, high blood pressure or on blood pressure medication, prediabetes, or abnormal blood lipids
  • Not institutionalized and able to read and consent
  • Willing to attend in-person study visits
  • Have access to and are comfortable using a smartphone and computer or tablet with internet
  • Understand Danish in writing and speaking
Not Eligible

You will not qualify if you...

  • Have a serious illness or cancer history in the past 5 years (except treated basal cell skin cancer or cervical in situ cancer)
  • Diagnosed with diabetes, cardiovascular events, or atrial fibrillation
  • Have psychiatric conditions or cognitive impairment
  • Are current smokers or use nicotine products
  • Have a BMI over 35 kg/m2
  • Abuse alcohol or drugs or drink more than Danish guidelines allow
  • Are pregnant or planning pregnancy within a year
  • Not willing to consume chicken and fish or make dietary changes
  • Have multiple food allergies affecting diet adherence
  • Any other condition causing doubt about eligibility by the study team

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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

CONTACT

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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