Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Low-density lipoprotein (LDL)
研究概览
简要总结
The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function.
详细描述
The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function. The specific aims are to conduct a preliminary examination of:
- The feasibility of Veterans to adopt a whole-food, plant-strong diet within five weeks, following a plant-strong protocol, or within 90 days following a Plant Strong Diet (PSD) using Culinary Rx, or by TeleMOVE! (standard of care control). Feasibility factors will evaluate acceptability and practicality by a measure of the recruitment process, attrition rate, reasons for dropping, perceived benefit, and comparison of dietary pattern changes before and after the intervention.
a. Acceptability of a plant-strong diet. 2. (Part 1) The effectiveness of a five-week whole-food, plant-strong diet on participants':
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Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), C-Reactive Protein (CRP), basic chemistry panel, blood pressure, weight, waist circumference, and percent body fat.
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Dietary pattern, particularly the degree to which meat, fish, dairy, and added oils are decreased or eliminated from the dietary pattern; as well as the degree to which the consumption of fruits and vegetables (particularly whole-food) are increased from baseline intake, and the nutrient composition (percent of calories from protein, fat, carbohydrate, and amount of fiber) of the diet changes.
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(Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90 days on participants':
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Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), HgbA1c, blood pressure, body mass index, weight, waist to hip ratio, and. medication usage (e.g., blood pressure, hypoglycemic, lipid lowering and anti-depressants).
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Dietary pattern, particularly the degree to which meat, fish, dairy, and added oils are decreased or eliminated from the dietary pattern; as well as the degree to which the consumption of fruits and vegetables (particularly whole-food) are increased from baseline intake, and the nutrient composition (percent of calories from protein, fat, carbohydrate, and amount of fiber) of the diet changes.
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Long-term lifestyle changes as measured by sustainability of dietary pattern and cardiovascular risk changes that occurred at 90 days and were still present at six months and one year, (excluding change in plaque inflammation and endothelial function).
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Establish the ability of Positron Emission Tomography 18F-fluorodeoxyglucose radiopharmaceutical and magnetic resonance imaging (PET FDG-MRI) to assess serial change in plaque inflammation and plaque volume (Part 2) and then perform a pilot test to assess whether a 90-day PSD using Culinary Rx, or TeleMOVE! reduces plaque inflammation using FDG uptake on PET scan and structural changes on MRI (Part 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor for the imaging studies will be blinded to the study arms of the subjects.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria: U.S. Veterans only
- •Age >18 and < 90
- •BMI >25 and < 40
- •Subject has hypertension, diabetes, hyperlipidemia, or overweight/obesity based upon recognized body mass index (BMI) standards) and an interest and desire to make a lifestyle change.Ability to tolerate two FDG-PET-MRI scans.
- •Active telephone contact information (either land line or cell phone)
- •No contraindication to be on a PSD.
- •Access to transportation and a functioning kitchen
- •The ability to prepare meals independently.
- •Access to a computer or tablet with internet access
- •Digital camera or Smartphone
- •For the FDG-PET-MRI subset/portion of the study, there are additional inclusion criteria:
- •Inclusion criteria:
- •Pooled risk cohort score ≥ 7.5%.
- •No contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes).
排除标准
- •Significant unplanned weight loss within the last six months
- •BMI < 25 or > 40
- •Uncontrolled insulin-dependent diabetes with a current HbA1C of over 9%
- •Contraindication to undertake a PSD
- •Age <18 years old
- •Pregnancy/lactation
- •Taking prescribed weight loss medication(s)
- •Currently following a plant-strong diet, vegan, or medical weight loss program diet
- •Celiac disease diagnosed within the last six months
- •End-stage hepatic disease or renal disease requiring dialysis
- •Active cancer or receiving chemotherapy or radiation therapy
- •Active alcohol or substance abuse problems
- •History of eating disorders
- •Fasting triglyceride level above 350 mg/dL
- •Any psychological issues that prevent compliance
- •Unable to speak the English language
- •Have limited mobility
- •Homeless or in housing with limited kitchen access
- •For the FDG-PET-MRI subset/portion of the study, there are additional exclusion criteria:
- •Inability to tolerate PET scans.
- •Contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes)
- •Women of childbearing potential who do not have medical documentation of surgically induced menopause.
研究组 & 干预措施
TeleMOVE!
Veterans randomized to the control arm will participate in TeleMOVE!, an arm of the Management of Overweight Veterans (MOVE!) program. TeleMOVE! is telehealth treatment program within the VA designed to improve the lives of Veterans by assisting with weight management and health promotion. This program includes daily interaction with in-home messaging technologies and clinician contact as needed
干预措施: TeleMOVE! (Behavioral)
Culinary Rx
Veterans randomized to the experimental arm will participate in Culinary Rx. Culinary Rx is an online instructional cooking and nutrition course that healthcare professionals can prescribe to patients who need to transition away from a Standard American Diet to a more health-supportive, whole foods, plant-based lifestyle. In partnership with The Plantrician Project, this course will focus on teaching the foundational cooking skills needed for long-term behavioral change, coupled with lifestyle education around nutrition and resources that will help users successfully face the many challenges inherent to dietary change.
干预措施: Culinary Rx (Behavioral)
结局指标
主要结局
Change in Low-density lipoprotein (LDL)
时间窗: 90 days, 6 months and one year from baseline
Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)
次要结局
- Change in carotid plaque(90 days from baseline)
- Change in Weight(90 days, 6 months and one year from baseline)
- Change in Hemoglobin A1C (HgbA1c)(90 days, 6 months and one year from baseline)
- Change in Total Cholesterol(90 days, 6 months and one year from baseline)
- Change in Dietary pattern(90 days, 6 months and one year from baseline)
- Change in aortic pulse wave velocity(90 days from baseline)
研究者
Diane Parrington
Deputy Associate Chief of Staff for Research
Phoenix VA Health Care System