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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134235
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Montgomery Heart & Wellness
Information provided by (Responsible Party):
Rami Najjar, 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.

Condition or disease Intervention/treatment Phase
Hypertension Elevated Cholesterol Overweight and Obesity Other: Dietary Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated measures, single group design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in serum total cholesterol [ Time Frame: Baseline and 4-weeks ]
    Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks

  4. 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

  5. Change in serum triglycerides [ Time Frame: Baseline and 4-weeks ]
    Triglycerides mg/dL was documented at baseline and after 4-weeks

  6. Change in serum insulin [ Time Frame: Baseline and 4-weeks ]
    Insulin (uU/mL) was documented at baseline and after 4-weeks

  7. Change in serum glucose [ Time Frame: Baseline and 4-weeks ]
    Serum glucose (mg/dL) was documented at baseline and after 4-weeks

  8. Change in serum hemoglobin A1c (HgA1c) [ Time Frame: Baseline and 4-weeks ]
    HgA1c (%) was documented at baseline and after 4-weeks

  9. Change in c-reactive protein (CRP) [ Time Frame: Baseline and 4-weeks ]
    CRP (mg/L) was documented at baseline and after 4-weeks

  10. Change in medication use [ Time Frame: Baseline, follow-up weeks 1-4 ]
    Medication needs were assessed weekly



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134235


Locations
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United States, Texas
Montgomery Heart & Wellness
Houston, Texas, United States, 77025
Sponsors and Collaborators
Texas Woman's University
Montgomery Heart & Wellness
Investigators
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Principal Investigator: Rami Najjar Texas Woman's University

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Demographics, anthropometrics, biochemical and nutrient intake data.

Publications:

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Responsible Party: Rami Najjar, Student, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03134235    
Other Study ID Numbers: 19279
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Overweight
Body Weight
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases