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Completed

NCT Number: NCT03134235

Effects of a 4-week Raw, Plant-based Diet on Anthropometric and 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Collaborators

  • Montgomery Heart & Wellness

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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