Clinical trial NCT03134235: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Elevated Cholesterol
Overweight and Obesity
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Montgomery Heart & Wellness
First posted: 2017-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures, single group design.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, follow-up weeks 1-4
measure: Change in serum low-density lipoprotein cholesterol (LDL)
timeFrame: Baseline and 4-weeks
measure: Change in blood pressure
timeFrame: Baseline, follow-up weeks 1-4
Secondary outcomes:
measure: Change in heart rate
timeFrame: Baseline, follow-up weeks 1-4
measure: Change in waist circumference
timeFrame: Baseline, follow-up weeks 1-4
measure: Change in serum total cholesterol
timeFrame: Baseline and 4-weeks
measure: Change in serum high-density lipoprotein cholesterol
timeFrame: Baseline and 4-weeks
measure: Change in serum triglycerides
timeFrame: Baseline and 4-weeks
measure: Change in serum insulin
timeFrame: Baseline and 4-weeks
measure: Change in serum glucose
timeFrame: Baseline and 4-weeks
measure: Change in serum hemoglobin A1c (HgA1c)
timeFrame: Baseline and 4-weeks
measure: Change in c-reactive protein (CRP)
timeFrame: Baseline and 4-weeks
measure: Change in medication use
timeFrame: Baseline, follow-up weeks 1-4
Other outcomes:
Locations:
city: Houston
country: United States
facility: Montgomery Heart & Wellness
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Rami Najjar
role: PRINCIPAL_INVESTIGATOR
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