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

May 19, 2017 updated by: Rami Najjar, Texas Woman's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77025
        • Montgomery Heart & Wellness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline, follow-up weeks 1-4
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)
Time Frame: Baseline and 4-weeks
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in blood pressure
Time Frame: Baseline, follow-up weeks 1-4
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
Time Frame: Baseline, follow-up weeks 1-4
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
Time Frame: Baseline, follow-up weeks 1-4
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
Time Frame: Baseline and 4-weeks
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in serum high-density lipoprotein cholesterol
Time Frame: Baseline and 4-weeks
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in serum triglycerides
Time Frame: Baseline and 4-weeks
Triglycerides mg/dL was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in serum insulin
Time Frame: Baseline and 4-weeks
Insulin (uU/mL) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in serum glucose
Time Frame: Baseline and 4-weeks
Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in serum hemoglobin A1c (HgA1c)
Time Frame: Baseline and 4-weeks
HgA1c (%) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in c-reactive protein (CRP)
Time Frame: Baseline and 4-weeks
CRP (mg/L) was documented at baseline and after 4-weeks
Baseline and 4-weeks
Change in medication use
Time Frame: Baseline, follow-up weeks 1-4
Medication needs were assessed weekly
Baseline, follow-up weeks 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

Montgomery Heart & Wellness

Investigators

  • Principal Investigator: Rami Najjar, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2017

Primary Completion (Actual)

March 8, 2017

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: Demographics, anthropometrics, biochemical and nutrient intake data.
  2. Study Protocol
  3. Statistical Analysis Plan
  4. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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