Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
Primary Purpose
Hypertension, Elevated Cholesterol, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
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
Sites / Locations
- Montgomery Heart & Wellness
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Raw, plant-based diet
Arm Description
A raw, plant-based diet was prescribed for 4 weeks.
Outcomes
Primary Outcome Measures
Change in body weight
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Change in serum low-density lipoprotein cholesterol (LDL)
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits
Secondary Outcome Measures
Change in heart rate
Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits
Change in waist circumference
Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits
Change in serum total cholesterol
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in serum high-density lipoprotein cholesterol
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Change in serum triglycerides
Triglycerides mg/dL was documented at baseline and after 4-weeks
Change in serum insulin
Insulin (uU/mL) was documented at baseline and after 4-weeks
Change in serum glucose
Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Change in serum hemoglobin A1c (HgA1c)
HgA1c (%) was documented at baseline and after 4-weeks
Change in c-reactive protein (CRP)
CRP (mg/L) was documented at baseline and after 4-weeks
Change in medication use
Medication needs were assessed weekly
Full Information
NCT ID
NCT03134235
First Posted
April 26, 2017
Last Updated
May 19, 2017
Sponsor
Texas Woman's University
Collaborators
Montgomery Heart & Wellness
1. Study Identification
Unique Protocol Identification Number
NCT03134235
Brief Title
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
Official Title
A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Montgomery Heart & Wellness
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Elevated Cholesterol, Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures, single group design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raw, plant-based diet
Arm Type
Experimental
Arm Description
A raw, plant-based diet was prescribed for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Time Frame
Baseline, follow-up weeks 1-4
Title
Change in serum low-density lipoprotein cholesterol (LDL)
Description
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits
Time Frame
Baseline, follow-up weeks 1-4
Secondary Outcome Measure Information:
Title
Change in heart rate
Description
Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits
Time Frame
Baseline, follow-up weeks 1-4
Title
Change in waist circumference
Description
Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits
Time Frame
Baseline, follow-up weeks 1-4
Title
Change in serum total cholesterol
Description
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum high-density lipoprotein cholesterol
Description
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum triglycerides
Description
Triglycerides mg/dL was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum insulin
Description
Insulin (uU/mL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum glucose
Description
Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum hemoglobin A1c (HgA1c)
Description
HgA1c (%) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in c-reactive protein (CRP)
Description
CRP (mg/L) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in medication use
Description
Medication needs were assessed weekly
Time Frame
Baseline, follow-up weeks 1-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Najjar
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montgomery Heart & Wellness
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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16873779
Citation
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Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://drive.google.com/file/d/0B3HECjLwDFbeLTctV3pic0pXUDA/view?usp=sharing
Available IPD/Information Comments
Demographics, anthropometrics, biochemical and nutrient intake data.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/file/d/0B3HECjLwDFbeYVhRYnVPVkZRbHc/view?usp=sharing
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://drive.google.com/file/d/0B3HECjLwDFbedGczRlRTMGtVRVk/view?usp=sharing
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://drive.google.com/file/d/0B3HECjLwDFbeNjNMZXhGSmY3dTQ/view?usp=sharing
Learn more about this trial
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
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