Montgomery Heart & Wellness
Houston, Texas, 77025, United States
NCT Number: NCT03134235
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Houston, Texas, 77025, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
Time frame: Baseline, follow-up weeks 1-4
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Time frame: Baseline and 4-weeks
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
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
Time frame: Baseline, follow-up weeks 1-4
Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits
Time frame: Baseline, follow-up weeks 1-4
Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits
Time frame: Baseline and 4-weeks
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
Triglycerides mg/dL was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
Insulin (uU/mL) was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
Serum glucose (mg/dL) was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
HgA1c (%) was documented at baseline and after 4-weeks
Time frame: Baseline and 4-weeks
CRP (mg/L) was documented at baseline and after 4-weeks
Time frame: Baseline, follow-up weeks 1-4
Medication needs were assessed weekly
Texas Woman's University
Other
A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
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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