Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
- Conditions
- Elevated CholesterolHypertensionOverweight and Obesity
- Interventions
- Other: Dietary Intervention
- Registration Number
- NCT03134235
- Lead Sponsor
- Texas Woman's University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Raw, plant-based diet Dietary Intervention A raw, plant-based diet was prescribed for 4 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 c-reactive protein (CRP) Baseline and 4-weeks CRP (mg/L) 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 insulin Baseline and 4-weeks Insulin (uU/mL) was documented at baseline and after 4-weeks
Change in serum hemoglobin A1c (HgA1c) Baseline and 4-weeks HgA1c (%) was documented at baseline and after 4-weeks
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 medication use Baseline, follow-up weeks 1-4 Medication needs were assessed weekly
Change in serum total cholesterol Baseline and 4-weeks Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in serum glucose Baseline and 4-weeks Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Trial Locations
- Locations (1)
Montgomery Heart & Wellness
🇺🇸Houston, Texas, United States