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

Not Applicable
Completed
Conditions
Elevated Cholesterol
Hypertension
Overweight and Obesity
Interventions
Other: Dietary Intervention
Registration Number
NCT03134235
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Raw, plant-based dietDietary InterventionA raw, plant-based diet was prescribed for 4 weeks.
Primary Outcome Measures
NameTimeMethod
Change in body weightBaseline, follow-up weeks 1-4

Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits

Change in serum low-density lipoprotein cholesterol (LDL)Baseline and 4-weeks

LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks

Change in blood pressureBaseline, 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
NameTimeMethod
Change in heart rateBaseline, follow-up weeks 1-4

Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits

Change in c-reactive protein (CRP)Baseline and 4-weeks

CRP (mg/L) was documented at baseline and after 4-weeks

Change in waist circumferenceBaseline, follow-up weeks 1-4

Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits

Change in serum insulinBaseline and 4-weeks

Insulin (uU/mL) was documented at baseline and after 4-weeks

Change in serum hemoglobin A1c (HgA1c)Baseline and 4-weeks

HgA1c (%) was documented at baseline and after 4-weeks

Change in serum high-density lipoprotein cholesterolBaseline and 4-weeks

Serum HDL (mg/dL) was documented at baseline and after 4-weeks

Change in serum triglyceridesBaseline and 4-weeks

Triglycerides mg/dL was documented at baseline and after 4-weeks

Change in medication useBaseline, follow-up weeks 1-4

Medication needs were assessed weekly

Change in serum total cholesterolBaseline and 4-weeks

Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks

Change in serum glucoseBaseline and 4-weeks

Serum glucose (mg/dL) was documented at baseline and after 4-weeks

Trial Locations

Locations (1)

Montgomery Heart & Wellness

🇺🇸

Houston, Texas, United States

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