Effects of Avocado on Triglyceride Metabolism in Individuals With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
研究概览
简要总结
In this study, Investigators are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance.
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. The research is designed as a randomized, 2-arm, parallel, diet-controlled, human clinical trial to investigate the effects of avocado consumption for 4 weeks on triglyceride metabolism in individuals with insulin resistance.
Participants will be asked to do the items described below. Visits will be held at the Clinical Nutrition Research Center (CNRC) on the Illinois Tech Campus, 10 W. 35th St., Suite 3D6-1 Chicago, IL, 60616.
SCREENING VISIT
Eligibility for the study is based on the above list (inclusion and exclusion criteria). Investigators will determine if participants qualify for the study at the Screening Visit by the following measurements:
- General measurements: height, weight, body composition, waist circumference, blood pressure, vitals and body temperature
- Fasting blood glucose (sugar) from a finger prick
- Venous blood collection to assess blood glucose, insulin, and triglycerides
- Pregnancy test, for women under the age of 60
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, 40-70 years of age.
- •Fasting triglycerides (TG) >115 mg/dL.
- •Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >2.
- •Able to provide informed consent.
- •Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (~ 80% of calories per day).
- •Able to come to the clinic up to 6 times during the study.
- •Able to maintain usual physical activity pattern.
- •Able to avoid/abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit.
排除标准
- •Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
- •Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure >160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
- •Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
- •Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
- •Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
- •Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.). - - Men and women who consume nuts or peanuts daily or most days of the week.
- •Men and women who are not weight stable (+/-10lbs in previous 2 months). Men and women who have excessive use of drugs or alcohol (ie., addictions) within the past 2 years.
- •Men and women with documented physical or mental disease/condition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- •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 the last 3 months.
- •Women who are taking an unstable dose and brand of hormonal contraceptives and/or a stable dose and brand for less than 6 months.
- •Unusual working hours (working overnight).
研究组 & 干预措施
Control meal plan
2 meals and snacks per day without the inclusion of avocado, covering 80% of daily calories needs.
干预措施: Control meal plan (Other)
Avocado meal plan
2 meals and snack per day including one avocado in the meal, covering 80% of daily calories need.
干预措施: Avocado meal plan (Other)
结局指标
主要结局
未指定
次要结局
- Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(baseline and 4 weeks)
- Changes in Low-Density Lipoprotein (LDL) cholesterol(baseline and 4 weeks)
- Changes in High-Density Lipoprotein (HDL) cholesterol(baseline and 4 weeks)
- Changes in non-High-Density Lipoprotein (HDL) cholesterol(baseline and 4 weeks)
- Changes in Connecting Peptide (C-peptide)(baseline and 4 weeks)
- Changes in Glucagon-Like Peptide-1(GLP-1)(baseline and 4 weeks)
- Inflammation markers-Interleukin (IL)-6(Baseline)
- Inflammation markers-Interleukin (IL)-10(Baseline)
- Inflammation markers-Tumor necrosis factor alpha (TNF-α)(Baseline)
- Nuclear Magnetic Resonance (NMR) Lipoprotein Subfraction(Baseline)