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临床试验/NCT05263011
NCT05263011已完成不适用

Effects of an Evening Snack Containing Avocado on Risk Factors for Diabetes in a Prediabetic Population

Clinical Nutrition Research Center, Illinois Institute of Technology2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月1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
50
试验地点
2
主要终点
Changes in plasma glucose concentration

研究概览

简要总结

Compare the effects of three evening snacks on morning fasting and postprandial glucose and insulin concentrations in individuals with prediabetes.

详细描述

The study is a single-center, randomized, single-blinded, 3-arm, and cross-over study design. Participants will be randomized to receive three eventing snack in randomized order: low-fiber, low-fat control snack (low-fat yogurt); whole avocado snack; or control snack + fiber supplement + vegetable oil, which will be consumed in the evening before the clinic visit. Twelve hours (12 h) after snack intake (based on subjects typical evening snack and morning breakfast routine), participants will report to the clinic for fasting blood draws, followed by a standard meal with a minimum of 50 g available carbohydrate, and repeated blood collection for 3 hours. On the day of "snack" intervention (ie., 24 h before standard meal testing), subjects will be guided to follow their typical dietary pattern in consultation with staff. Food diaries with a general plan will be used as a tool to help with dietary compliance.

STUDY PROCEDURES: SCREENING VISIT:

Interested subjects will be asked to come to the Clinical Nutrition Research Center (CNRC) on the IIT Campus, Chicago, IL, where the study will take place for a screening visit to determine if they are eligible to participate in the study. The screening visit will take 2 hours. Prospective subjects must read, sign and date a written Institutional Review Board (IRB) approved Informed Consent Form prior to performing any study procedure.

At the on-site screening visit, subject will be asked to arrive after overnight fasting for 10-12 hours and be well-hydrated. Subject will be instructed to aim for a water intake of at least 8-10 cups for the 24 hours before the screening visit. Determining eligibility to participate includes having subjects to complete a series of questionnaires related to their health, medication use, dietary habits, and physical activity history. Anthropometrics (height, weight and waist circumference), body composition, ear temperature, and vital signs (blood pressure and heart rate) will be measured. For women under the age of 60 years, a pregnancy test will be conducted. Body mass index (BMI) will be calculated from height and weight measurements. Fasting blood glucose level by capillary blood from finger prick will be tested. For vital sign measurements, subjects will sit in a comfortable chair, feet uncrossed and on the floor and will be asked to rest quietly for 5 minutes before measuring blood pressure and heart rate. Arm vein will be assessed using a vein access scale test. Subject will be instructed to complete a 24-hour food recall.

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 and instructed to record all food and beverages consumed for a 24 hour period on food record diarie using ASA24. Subjects will be asked not to take any allergy medications and/or any pain medications such as Aspirin, Excedrin, Ibuprofen (Advil, Motrin, Nuprin), Naproxen, or Aleve within 48 hours of each scheduled study days. Tylenol is allowed. If they need to take allergy/pain medication 48 hours prior to their study day, we will ask them to let the study investigators know so they can be rescheduled. Before leaving the CNRC, subjects will be provided with written instruction for "how to prepare for your study visit". This will include instructions for eating a standardized dinner meal the night before the study day, consume the assigned study snacks, 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 and usual diet except for the guidance provided for "foods and beverages to avoid or limit". If subject did not get enough sleep during the night preceding a study day, we will ask them to let us know so we can reschedule their study day.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Men or women, age 25-70 years
  • Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at screening visit
  • Blood pressure 120-160 mmHg systolic or 80-100 mm/Hg diastolic at screening visit
  • Nonsmokers (past smokers can be allowed if they have abstinence for minimum of 12 months)
  • Judged to be in good health on the basis of the medical history (i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease)
  • Not taking any medications that would interfere with outcomes of the study, (e.g., lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc.)
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol (follow the dietary plans, come to scheduled visits, record food intake in a diary, complete questionnaires, provide blood samples and complete other tests (eye and brain/cognitive function)
  • Able to maintain usual physical activity pattern
  • Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during the study visit

排除标准

  • Men and women who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
  • Men and women who have fasting blood glucose concentration <100 or >125 mg/dL at screening visit
  • Men and women with diabetes
  • History of a cardiovascular event, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery (e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc.) that, in the opinion of the investigator, could interfere with the interpretation of the study results
  • Head injury in past 6 months
  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years
  • Taking medication or dietary supplements that may interfere with the outcomes of the study, (e.g., antioxidant supplement, anti-inflammation, lipid-lowering medication, blood pressure-lowering medication, etc.). Subjects may choose to go off dietary supplements (requires 30-day washout; e.g., fish oil, etc.)
  • Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator
  • Known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
  • Current smoker or smoked/vaped within the last 12 months
  • Unstable weight: Actively losing or gaining weight or trying to lose or gain weight. Gained or lost weight +/- 5 kg (11 lbs.) in previous 2 months.
  • Substance (alcohol or drug) abuse within the last 2 years
  • Present with significant psychiatric or neurological disturbances
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating
  • Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
  • Has used antibiotics within the previous 2 months
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
  • Excessive coffee and tea consumers (> 4 cups/d)
  • Donated blood within last 3 months
  • Men and women who do excessive exercise regularly or are an athlete
  • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
  • Unusual working hours (e.g., working overnight; 3rd shift)

结局指标

主要结局

Changes in plasma glucose concentration

时间窗: time 0-180 minutes

will be analyzed by a Randox automated clinical analyzer

Changes in plasma insulin concentration

时间窗: time 0-180 minutes

will be analyzed by a Randox automated clinical analyzer

Changes in plasma triglycerides concentration

时间窗: time 0-180 minutes

will be analyzed by a Randox automated clinical analyzer

Changes in plasma Interleukin (IL)-6 concentration

时间窗: time 0-3 hours

will be analyzed by ELISA or EIA using purchased kits and reagents from R\&D systems

Changes in plasma tumor necrosis factor (TNF)-alpha, concentration

时间窗: time 0-3 hours

will be analyzed by ELISA or EIA using purchased kits and reagents from R\&D systems

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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