N/A
N=118
Prevention of Cardiovascular Disease With Med or Veg Diets
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02641834 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Changes in Body Weight From Baseline — -1.88; -1.77 Kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vegetarian diet (Other); Mediterranean diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Body Weight From Baseline |
-1.88; -1.77 | — |
| SECONDARY Changes in Fat Mass From Baseline |
-1.23; -1.46 | — |
| SECONDARY Changes in BMI From Baseline |
-0.64; -0.67 | — |
| SECONDARY Changes in Total Cholesterol From Baseline |
-5.34; -0.11 | — |
| SECONDARY Changes in LDL Cholesterol From Baseline |
-6.98; 2.12 | — |
| SECONDARY Changes in Triglycerides From Baseline |
5.92; -6.78 | — |
| SECONDARY Changes in Glucose From Baseline |
0.54; 0.27 | — |
| SECONDARY Changes in TBARS From Baseline |
-0.39; -0.32 | — |
| SECONDARY Changes in L-derived ROS From Baseline |
-59.62; -17.56 | — |
| SECONDARY Changes in Interleukin-17 From Baseline |
1.39; -2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02641834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.