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Prevention of Cardiovascular Disease With Med or Veg Diets (CARDIVEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641834
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Vegetarian diet Other: Mediterranean diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Cardiovascular Disease With the Vegetarian Diet: the CARDIVEG Study
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vegetarian Diet

Arm Intervention/treatment
Experimental: Veg Group
Group that starts with the Vegetarian diet
Other: Vegetarian diet
7-days dietary profile with an isocaloric Vegetarian diet for 3 months

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

Active Comparator: Med group
Group that starts with the Mediterranean diet
Other: Vegetarian diet
7-days dietary profile with an isocaloric Vegetarian diet for 3 months

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




Primary Outcome Measures :
  1. Weight change [ Time Frame: 6 months ]
    Change in weight from baseline


Secondary Outcome Measures :
  1. Total fat mass change [ Time Frame: 6 months ]
    Change in total fat mass from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-75 years
  2. Willing and able to give informed consent
  3. Presence of at least one of the following risk factors for cardiovascular disease (European Society of Cardiology guidelines on cardiovascular disease prevention):

    • BMI > 25.1 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)
    • Levels of blood pressure > 130/85 mmHg, non-pharmacological treatment (measurement carried out for more than 2 consecutive times on different days and on both arms)
  4. Wiling to participate in a randomized study comparing two dietary profiles, one of which is a vegetarian dietary pattern
  5. Successfully completed 2-day food diary
  6. Wiling to be contacted at least twice during the study period to evaluate diet compliance
  7. Wiling to provide blood and fecal samples

Exclusion Criteria:

  1. 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)
  2. Pregnancy or intention to become pregnant in next 18 months
  3. Lactation
  4. Current or recent (past 6 months) participation in weight loss treatment program or use of weight loss medication
  5. Reporting no regular intake of meat, fish, or poultry for past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641834


Locations
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Italy
Unit of Clinical Nutrition, University Hospital of Careggi
Florence, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Study Director: Alessandro Casini, MD Unit of Clinical Nutrition, University Hospital of Careggi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Sofi, Associate Professor of Clinical Nutrition, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02641834    
Other Study ID Numbers: CAR-123-VEG
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi:
diet
vegetarian
cardiovascular risk
Additional relevant MeSH terms:
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Cardiovascular Diseases