Habitual Diet and Avocado Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,008
- 试验地点
- 8
- 主要终点
- Visceral adiposity
研究概览
简要总结
The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).
详细描述
Preliminary evidence suggests that consumption of avocados can modulate body weight, food intake and markers of metabolic syndrome and may reduce visceral adiposity. Visceral adipose tissue is positively correlated with risk of cardiometabolic syndrome that predisposes to cardiovascular disease and diabetes. The Habitual Diet and Avocado Trial (HAT) aims to investigate an impactful outcome (visceral fat reduction) in a relevant population (Americans with an increased weight circumference) with a reasonable lifestyle modification (consumption of 1 avocado per day). HAT will evaluate the effect of providing one avocado per day for consumption over a 6 month period on established health parameters, including visceral adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity C-reactive protein (hsCRP) when compared to a habitual diet. Blood specimens will be drawn and analyzed for fasting total cholesterol, triglyceride, HDL-C, glucose, insulin, hsCRP and RBC fatty acid profiles. Two non-contrast MRIs will be performed (at screening to assess eligibility and final participant visit 8 for randomized participants) to assess the volume of visceral adipose tissue and hepatic fat fraction. Four 24-hour dietary recalls will be conducted for study participants to capture dietary intake data. Questionnaires include the following: health and demographic including eating habits and physical activity; diet, food and avocado satisfaction (intervention group only); quality of life; and quality of sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Increased waist circumference defined as ≥35 inches for women, ≥40 inches for men
- •At least 25 years old at screening
- •Not currently eating more than 2 avocados per month (habitual intake in U.S.)
排除标准
- •Does not eat avocados
- •Sensitive / allergic to avocados
- •Allergies to latex or oral allergy syndrome
- •Not willing or unable to undergo MRI scans
- •Unstable medical condition such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer >5 years ago acceptable, any cancer site >10yrs without recurrence).
- •Pregnant, lactating, intention of pregnancy
- •Lost or gained 10 lbs of body weight in last year
- •Following restricted or weight loss dietary patterns
- •Unstable anti-anxiety / anti-depressive / anti-psychotic medication use defined as dose change within last 6 months
- •Oral steroid use within the last 6 months longer than 7 days
- •Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)
- •Participation in another clinical intervention trial within 30 days of baseline
- •PI judgment
结局指标
主要结局
Visceral adiposity
时间窗: Visit 1 (Screening, -2 to 0 weeks) and Visit 8 (26 weeks)
Non-contrast MRI scans will be performed to assess the volume of visceral adipose tissue. The outcome will be pre-post difference, compare the estimated mean change from baseline to follow-up in the 2 randomized groups with all tests of group differences performed according to the intent to treat.
次要结局
- High-sensitivity C-reactive protein (hs-CRP)(Visit 2 (baseline/randomization, Week 0), Visit 5 (12 weeks), Visit 8 (26 weeks))
- Quality of life RAND 36-Item Short Form Survey Instrument (SF-36)(Visit 2 (baseline), Visit 5 (12 weeks) and Visit 8 (26 weeks-final))
- Hepatic lipid content(Visit 1 (Screening, -2 to 0 weeks and Visit 8 (26 weeks))
- Diet, Food and Avocado Satisfaction(Visit 2 (baseline/randomization, 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks))
- Metabolic syndrome markers (serum triglycerides, serum cholesterol, fasting serum glucose, fasting insulin)(Visit 2 (Baseline visit 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks))
- Red blood cell (RBC) monounsaturated fat/polyunsaturated fat (MUFA/PUFA) ratio(Visit 2 (Baseline/Randomization Visit, 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks))
- Blood pressure(Visit 2 (baseline/randomization 0 weeks) Visit 3 (4 weeks), Visit 4 (8 weeks), Visit 5 (12 weeks), Visit 6 (16 weeks), Visit 7 (10 weeks), Visit 8 (26 weeks))
- Weight(Visit 2 (baseline/randomization), Visit 5 (12 weeks) and Visit 8 (26 weeks-final))
- Quality of Life RAND 20-Item Short Form Survey (SF-20)(Visit 3 (4 weeks), Vist 4 (8 weeks) Visit 6 (16 weeks), Visit 7 (20 weeks))
- Sleep quality(Visit 2 (baseline), Visit 5 (12 weeks) and Visit 8 (26 weeks-final))
- Waist circumference(Visit 1 (screening -2 to 0 weeks), Visit 2 (baseline/randomization 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks))
- 24-hour diet recall(Visit 1 (screening, -2 to 0 weeks), Visit 4 (8 weeks), visit 6 (16 weeks), Visit 8 (26 weeks))