Trial Outcomes & Findings for Prevention of Cardiovascular Disease With Med or Veg Diets (NCT NCT02641834)
NCT ID: NCT02641834
Last Updated: 2021-09-27
Results Overview
Changes in Body Weight From Baseline
COMPLETED
NA
118 participants
baseline and 6 months
2021-09-27
Participant Flow
Participant milestones
| Measure |
Veg Group
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
Group that starts with the Mediterranean diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Cardiovascular Disease With Med or Veg Diets
Baseline characteristics by cohort
| Measure |
Veg Group
n=60 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=58 Participants
Group that starts with the Mediterranean diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
n=5 Participants
|
52 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in Body Weight From Baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Body Weight From Baseline
|
-1.88 Kilograms
Interval -2.42 to -1.35
|
-1.77 Kilograms
Interval -2.29 to -1.25
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in fat mass from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Fat Mass From Baseline
|
-1.23 percentage of fat mass
Interval -1.67 to -0.8
|
-1.46 percentage of fat mass
Interval -1.93 to -1.01
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in BMI from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in BMI From Baseline
|
-0.64 kg/m^2
Interval -0.84 to -0.43
|
-0.67 kg/m^2
Interval -0.86 to -0.47
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in total cholesterol from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Total Cholesterol From Baseline
|
-5.34 mg/dL
Interval -10.24 to -0.73
|
-0.11 mg/dL
Interval -4.36 to 4.09
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in LDL cholesterol from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in LDL Cholesterol From Baseline
|
-6.98 mg/dL
Interval -11.06 to 2.16
|
2.12 mg/dL
Interval -2.26 to 5.6
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in triglycerides from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Triglycerides From Baseline
|
5.92 mg/dL
Interval -1.16 to 16.41
|
-6.78 mg/dL
Interval -14.76 to -2.72
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in glucose from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Glucose From Baseline
|
0.54 mg/dL
Interval -0.97 to 2.43
|
0.27 mg/dL
Interval -1.13 to 1.53
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in TBARS from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in TBARS From Baseline
|
-0.39 pg/mL
Interval -0.65 to -0.09
|
-0.32 pg/mL
Interval -0.65 to -0.09
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in L-derived ROS from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in L-derived ROS From Baseline
|
-59.62 RFU
Interval -105.17 to 6.72
|
-17.56 RFU
Interval -79.89 to 26.32
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: All data were treated as paired samples from a crossover study. The 2 interventions were analyzed combining the results obtained in the 2 phases of both groups. As a total of 107 participants completed ≥1 phase of intervention and were included in the analysis, the overall number of participants in each dietary group is greater than the number stated in the participant flow.
Changes in Interleukin-17 from baseline
Outcome measures
| Measure |
Veg Group
n=104 Participants
Group that starts with the Vegetarian diet
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
|
Med Group
n=103 Participants
Group that starts with the Mediterranean diet
Mediterranean diet: 7-days dietary profile with an isocaloric Mediterranean diet for 3 months
Vegetarian diet: 7-days dietary profile with an isocaloric Vegetarian diet for 3 months
|
|---|---|---|
|
Changes in Interleukin-17 From Baseline
|
1.39 pg/mL
Interval -0.62 to 1.84
|
-2 pg/mL
Interval -3.51 to -0.01
|
Adverse Events
Veg Group
Med Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Francesco Sofi
Department of Experimental and Clinical Medicine, University of Florence, Italy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place