Health Trials

Sustainable Diets and Cardiometabolic Health

ConditionCardiometabolic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorUniversity of Copenhagen

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dietary advice (PHD)
  • Dietary advice (Ovo-lacto-vegetarian diet)
  • Dietary advice (control)
  • Behavioural support PHD
  • Food boxes PHD
  • Group visits PHD
  • Behavioural support (Ovo-lacto-vegetarian diet)
  • Food boxes (Ovo-lacto-vegetarian diet)
  • Group visits (Ovo-lacto-vegetarian diet)
  • Behavioral support (control)
  • Food boxes (control)
  • Group visits (control)

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Copenhagen

Lead sponsor

Novo Nordisk Foundation (NNF)

Collaborator

Danish Heart Foundation

Collaborator

Source ClinicalTrials.gov