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临床试验/NCT05009420
NCT05009420已完成不适用

Validation of Avocatin b as a Biomarker of Food Intake for Assessing the Acute Consumption of Avocado in Free-living Individuals

Clinical Nutrition Research Center, Illinois Institute of Technology2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
changes in avocatin b (C17 lipid) concentration in plasma in healthy individuals, 24 hours after consumed 1 avocado.

研究概览

简要总结

The primary objectives are to

  • Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado.
  • Confirm no avocation b present in the plasma of individuals that avoided avocado intake for 7 days.
  • Determine the effect of an overnight fast on avocation b detection.

详细描述

The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening. SCREENING To learn more about the study and to pre-qualify, potential subjects can call the CNRC or visit the website posted on recruitment flyers or from other recruitment materials. If they call the CNRC, a staff member will provide a brief background on the study and ask a series of questions from a screening questionnaire to see if they may be eligible to participate. The same questionnaire is available on the website and can be filled out by potential subjects online. The screening questionnaire includes self-reported information about health status and lifestyle factors that can be used to determine if someone is not eligible for the study (i.e.: has diabetes, cardiovascular disease, on interfering meds, etc...).

Based on the results of the questionnaires, BMI calculation, and health evaluation, subjects who meet the inclusion and exclusion criteria will be invited to participate in the study. Eligible subjects will be trained on "how to prepare for study visit". This will include instructions for avoiding avocados for at least 7 days prior to the study Visit, fasting overnight (10-12 hours), avoidance of vigorous physical activity, alcoholic and caffeinated beverage consumption for at least 24 hours preceding a study day, maintain regular sleep pattern. If the subject did not get enough sleep during the night preceding a study day, the investigators will reschedule their study day.

STUDY DAY:

Study Day visit will last about 1.5 hours with a 30 minutes follow-up visit 24 h after the start of the study treatment.

On a Study Day visit, subjects will arrive at the clinic after fasting for at least 10 hours and in a well-hydrated and well-rested state. Subjects will be inquired for compliance to avocado-free food at least 7 days prior to study day and details of food intake in the 24-hour period prior to the visit to ensure consistency and compliance with the protocol requirements. After confirming compliance with the [ protocol, anthropometric measurements, vital signs (blood pressure, heart rate, and ear temperature) will be taken.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25-35
  • Males/females
  • 25-70 years of age

排除标准

  • Does not eat avocados for a reason prohibiting them from being willing to eat 1 avocado
  • Sensitive/allergic to avocados
  • Allergies to latex or oral allergy syndrome
  • Unstable medical conditions 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 15 lbs of body weight in last 2 months
  • Following restricted or weight loss dietary patterns
  • Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)

结局指标

主要结局

changes in avocatin b (C17 lipid) concentration in plasma in healthy individuals, 24 hours after consumed 1 avocado.

时间窗: baseline (time point 0) to 24 hours

fasting blood sample before eating a avocado compare with fasting blood sample 24 hours after consumed 1 avocado.

次要结局

  • avocatin b (C17 lipid) concentration in plasma of individuals that avoided avocado intake for 7 days(Day-7-Day0)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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