The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dietary Vegetable Intake
研究概览
简要总结
The purpose of the investigators study is to investigate the impact of a commercial vegetable juice on dietary vegetable intake and select cardiovascular risk factors in a generally healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •***Inclusion Criteria***
- •Age 40 to 65 yrs
- •Subject's body mass index is between 18.5 - 34.9 kg/m2
- •Subject is willing and able to comply with the study protocols
- •Subject is willing to consume a vegetable-based beverage daily for three months
排除标准
- •Physical signs of health impairment
- •Uncontrolled diabetes or hypertension
- •Pregnant or lactating
- •Active tuberculosis or lung disease (i.e. COPD)
- •Renal or Liver disease
- •Heart Disease, which includes Cardiovascular events and Stroke
- •Cushing's syndrome
- •Exercise trained individuals
- •History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year
- •Anxiety medications
- •Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)
- •Quality of life score of 21 or above
- •Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs
- •Asthma (can be worsened by mild to moderate food allergies)
- •Indications of substance or alcohol abuse within the last 3 years
- •The volunteer is undergoing nicotine cessation therapy
- •Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin
- •Individuals with known salt-sensitive hypertension
- •History of stage 1 high blood pressure defined as systolic > 140 and diastolic > 90, with or without use of HTN medications
- •Multi-Vitamin use other than a One-A-Day essential
- •Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study
- •Allergies to vegetables
研究组 & 干预措施
Control
0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
8 fluid ounces vegetable juice
8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
干预措施: Vegetable Juice (Other)
16 fluid ounces vegetable juice
16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
干预措施: Vegetable Juice (Other)
结局指标
主要结局
Dietary Vegetable Intake
时间窗: 6 and 12 weeks
Dietary Nutrient Intake (vitamins & minerals)
时间窗: 6 and 12 weeks
次要结局
- Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)(0, 6 and 12 weeks)