Prevention of Cardiovascular Disease With Med or Veg Diets

NCT02641834 | Completed Results

• 1 other identifier: CAR-123-VEG
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet would benefit the cardiovascular risk profile of the participants, compared with a Mediterranean diet.

Conditions

Cardiovascular Disease

Keywords

diet; vegetarian; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Changes in Body Weight From Baseline

  Changes in Body Weight From Baseline

  baseline and 6 months

Secondary Outcomes (9)

• Changes in Fat Mass From Baseline

  baseline and 6 months

• Changes in BMI From Baseline

  baseline and 6 months

• Changes in Total Cholesterol From Baseline

  baseline and 6 months

• Changes in LDL Cholesterol From Baseline

  baseline and 6 months

• Changes in Triglycerides From Baseline

  baseline and 6 months

Study Arms (2)

Veg Group

EXPERIMENTAL

Group that starts with the Vegetarian diet

Other: Vegetarian diet; Other: Mediterranean diet

Med group

ACTIVE COMPARATOR

Group that starts with the Mediterranean diet

Other: Vegetarian diet; Other: Mediterranean diet

Interventions

Vegetarian diet OTHER

7-days dietary profile with an isocaloric Vegetarian diet for 3 months

Med group; Veg Group

Mediterranean diet OTHER

7-days dietary profile with an isocaloric Mediterranean diet for 3 months

Med group; Veg Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Willing and able to give informed consent
• Presence of at least one of the following risk factors for cardiovascular disease (European Society of Cardiology guidelines on cardiovascular disease prevention):
• BMI \>o= 25 kg/m2
• Waist circumference \> 88 cm (women) or \> 102 cm (men)
• Circulating levels of total cholesterol \> 190 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
• Circulating levels of LDL cholesterol \> 115 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
• Levels of circulating triglycerides \> 150 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
• Circulating levels of fasting blood glucose \> 110 and \< 126 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
• Wiling to participate in a randomized study comparing two dietary profiles, one of which is a vegetarian dietary pattern
• Successfully completed 3-day food diary
• Wiling to be contacted at least twice during the study period to evaluate diet compliance
• Wiling to provide blood and fecal samples

You may not qualify if:

• Presence of current serious illness or unstable condition that requires physician supervision of diet or physical activity (e.g., recent myocardial infarction, chronic liver disease, inflammatory bowel diseases)
• Pregnancy or intention to become pregnant in next 18 months
• Lactation
• Current or recent (past 6 months) participation in weight loss treatment program or use of weight loss medication
• Reporting no regular intake of meat, fish, or poultry for past month

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Unit of Clinical Nutrition, University Hospital of Careggi

Florence, 50134, Italy

Location

Related Publications (4)

• Pagliai G, Tristan Asensi M, Dinu M, Cesari F, Bertelli A, Gori AM, Giusti B, Marcucci R, Sofi F, Colombini B. Effects of a dietary intervention with lacto-ovo-vegetarian and Mediterranean diets on apolipoproteins and inflammatory cytokines: results from the CARDIVEG study. Nutr Metab (Lond). 2024 Feb 1;21(1):9. doi: 10.1186/s12986-023-00773-w.

  PMID: 38302995 DERIVED

• Ronca A, Pellegrini N, Pagliai G, Dinu M, Manfredini M, Incerti M, Favari E, Sofi F. Effects of a dietary intervention with Mediterranean vs lacto-ovo vegetarian diets on HDL function: Results from the CARDIVEG study. Nutr Metab Cardiovasc Dis. 2023 Mar;33(3):651-658. doi: 10.1016/j.numecd.2022.11.012. Epub 2022 Nov 24.

  PMID: 36642608 DERIVED

• Sofi F, Dinu M, Pagliai G, Cesari F, Gori AM, Sereni A, Becatti M, Fiorillo C, Marcucci R, Casini A. Low-Calorie Vegetarian Versus Mediterranean Diets for Reducing Body Weight and Improving Cardiovascular Risk Profile: CARDIVEG Study (Cardiovascular Prevention With Vegetarian Diet). Circulation. 2018 Mar 13;137(11):1103-1113. doi: 10.1161/CIRCULATIONAHA.117.030088. Epub 2018 Feb 26.

  PMID: 29483085 DERIVED

• Sofi F, Dinu M, Pagliai G, Cesari F, Marcucci R, Casini A. Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial. Trials. 2016 May 4;17(1):233. doi: 10.1186/s13063-016-1353-x.

  PMID: 27145958 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Diet, Vegetarian; Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

Some limitations are present, such as the limited duration of the study. Studies with a larger population and a longer duration are needed to confirm these results.

Results Point of Contact

• Title: Prof. Francesco Sofi
• Organization: Department of Experimental and Clinical Medicine, University of Florence, Italy

francescosofi@gmail.com

+390557949429

Study Officials

• Alessandro Casini, MD

  Unit of Clinical Nutrition, University Hospital of Careggi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Nutrition

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 27, 2021
• Results First Posted: September 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)