Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors

Study Overview
=================
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.

Official Title
-----------------
A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors

Conditions
-----------------
Hypertension, Elevated Cholesterol, Overweight and Obesity

Intervention / Treatment
-----------------
* Other: Dietary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Repeated measures, single group design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raw, plant-based diet<br>A raw, plant-based diet was prescribed for 4 weeks. | Other: Dietary Intervention<br>* Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits | Baseline, follow-up weeks 1-4 | 
| Change in serum low-density lipoprotein cholesterol (LDL) | LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits | Baseline, follow-up weeks 1-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits | Baseline, follow-up weeks 1-4 | 
| Change in waist circumference | Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits | Baseline, follow-up weeks 1-4 | 
| Change in serum total cholesterol | Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum high-density lipoprotein cholesterol | Serum HDL (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum triglycerides | Triglycerides mg/dL was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum insulin | Insulin (uU/mL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum glucose | Serum glucose (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum hemoglobin A1c (HgA1c) | HgA1c (%) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in c-reactive protein (CRP) | CRP (mg/L) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in medication use | Medication needs were assessed weekly | Baseline, follow-up weeks 1-4 |