N/A
N=60
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
Cardiovascular Disease · Hypercholesterolemia · Obesity · Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT01817491 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Change in Body Mass Index BMI Percentile — -1.12; -0.08; -1.29; -0.73 BMI percentile
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- American Heart Association Diet (Other); Reduced Fat Vegan Diet (Other)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index BMI Percentile |
-1.12; -0.08; -1.29; -0.73 | — |
| PRIMARY Children Change in BMI Z Score |
-0.14; -0.03 | — |
| PRIMARY Change in Blood Pressure (BP) |
-6.43; -5.14; -7.96; -3.14; -2.61; -4.36 | — |
| PRIMARY Change in Weight |
-3.05; -1.55; -3.64; -2.01 | — |
| PRIMARY Change in Circumference |
-1.53; -2.96; -1.94; -0.49; -2.02; -1.14 | — |
| PRIMARY Change in PAQ (Physical Activity Questionnaire) |
0.22; -0.16 | — |
| PRIMARY Change in Lipid Profile |
-22.50; -16.50; -25.50; -13.14; -5.93; -2.93 | — |
| PRIMARY Change in Glucose |
0.93; -.64; 4.93; -5.43 | — |
| PRIMARY Change in hsCRP (High-sensitivity C-reactive Protein) |
-2.09; 2.78; -0.24; 0.21 | — |
| PRIMARY Change in Liver Enzymes |
0.79; -1.14; 2.79; 0.00; 0.86; 4.57 | — |
| PRIMARY Change in IL-6 (Interleukin-6) |
-0.17; -0.19; 0.16; -0.19 | — |
| PRIMARY Change in MPO (Myeloperoxidase) |
-75.34; -69.23; 16.91; 1.78 | — |
| PRIMARY Change in HgbA1c (Hemoglobin A1c) |
0.17; 0.21; -0.16; 0.14 | — |
| PRIMARY Change in Insulin |
-5.42; 3.16; -3.11; -3.15 | — |
| SECONDARY PB/AHA - Adjusted Mean Difference BMI |
-1.17; -0.69 | — |
| SECONDARY PB/AHA - Adjusted Mean Difference BMI Z Score Children |
-0.13 | — |
| SECONDARY PB/AHA - Adjusted Mean BP |
1.87; 1.01; 0.97; 1.03 | — |
| SECONDARY PB/AHA - Adjusted Mean Difference Weight |
-1.71; -1.95 | — |
| SECONDARY PB/AHA - Adjusted Mean Difference Circumference |
1.32; -1.14; -1.25; -1.68 | — |
| SECONDARY PB/AHA - Adjusted Mean Difference PAQ Children |
0.39 | — |
| SECONDARY PB/AHA - Adjusted Mean Lipid Profile |
-10.34; 1.01; 0.17; 0.95; -27.29; 0.95 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio Glucose |
1.01; 1.06 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio hsCRP |
0.46; 0.68 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio Liver Enzymes |
1; 1.13; 0.85; 0.83 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio IL-6 |
0.26; 1.14 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio MPO |
0.95; 0.93 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio HgbA1c |
0.99; 0.96 | — |
| SECONDARY PB/AHA - Adjusted Mean Ratio Insulin |
0.7; 0.87 | — |
Summary
The purpose of this study is to investigate the short-term effects of a reduced fat plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk. This plant-based diet consists of whole grains, fruits and vegetables and little amounts of nuts and seeds, with no limitations on the amount of food intake. Animal products are not allowed. The results of the plant-based diet will be compared with the diet recommended by American Heart Association. This diet also emphasizes fruits and vegetables, but allows healthy fats, low-fat meats, fish and low-fat dairy in moderation. The results of the study might be useful in understanding whether or not plant-based diets are protective against cardiovascular disease.
Eligibility Criteria
Inclusion Criteria
- Children ages 9-18
- BMI > 95th percentile
- Hypercholesterolemia (>169 mg/dl)
Exclusion Criteria
- Pregnant women
- Patients already on vegetarian diets
Data sourced from ClinicalTrials.gov (NCT01817491). 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.