Elevated Cholesterol, Hypertension, Overweight and Obesity
Conditions
Brief summary
This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.
Detailed description
Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators. Participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods, free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits. Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.
Interventions
OTHERDietary Intervention
Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
Sponsors
Montgomery Heart & Wellness
Texas Woman's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Repeated measures, single group design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index ≥25.0 kg/m\^2 * Serum low-density lipoprotein cholesterol concentration ≥100 * Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
Exclusion criteria
* Tobacco use * Drug abuse * Excessive alcohol consumption (\>2 glasses of wine or alcohol equivalent per day for men or \>1 glass of wine or alcohol equivalent for woman) * Current cancer diagnosis * Estimated glomerular filtration rate \<60 mg/dL * Clinically defined infection * Mental disability * Hospitalization \<6 months * Previous exposure to plant-based diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, follow-up weeks 1-4 | Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits |
| Change in serum low-density lipoprotein cholesterol (LDL) | Baseline and 4-weeks | LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks |
| Change in blood pressure | Baseline, follow-up weeks 1-4 | Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum high-density lipoprotein cholesterol | Baseline and 4-weeks | Serum HDL (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum triglycerides | Baseline and 4-weeks | Triglycerides mg/dL was documented at baseline and after 4-weeks |
| Change in serum insulin | Baseline and 4-weeks | Insulin (uU/mL) was documented at baseline and after 4-weeks |
| Change in heart rate | Baseline, follow-up weeks 1-4 | Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits |
| Change in serum hemoglobin A1c (HgA1c) | Baseline and 4-weeks | HgA1c (%) was documented at baseline and after 4-weeks |
| Change in c-reactive protein (CRP) | Baseline and 4-weeks | CRP (mg/L) was documented at baseline and after 4-weeks |
| Change in medication use | Baseline, follow-up weeks 1-4 | Medication needs were assessed weekly |
| Change in serum glucose | Baseline and 4-weeks | Serum glucose (mg/dL) was documented at baseline and after 4-weeks |
| Change in waist circumference | Baseline, follow-up weeks 1-4 | Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits |
| Change in serum total cholesterol | Baseline and 4-weeks | Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks |
Countries
United States
Outcome results
None listed