Macro- and Micro- Vascular Function and Related Cognitive Effects in Response to Dietary Exchanges With Avocado and Mango in Pre-diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Changes in Pulse Wave Velocity
研究概览
简要总结
The research is designed as a randomized, 2-arm, parallel, controlled, human clinical trial to investigate the effects of avocado and mango consumption for 8 weeks on indices of macro- and micro- vascular function in individuals with prediabetes. FMD of the brachial artery, pulse wave velocity (PWV), central blood pressure (cBP), and Optical Coherence Tomography Angiography (OCTA) of the eye will be used for vascular assessments. The research plan will also explore cognitive and kidney function benefits of regular avocado and mango intake using specified cognitive tasks and kidney function biomarkers
详细描述
Recruited subjects must meet all eligibility criteria, sign and date a written Institutional Review Board (IRB)-approved Informed Consent Form.
The trial will test 2 dietary conditions which will be fresh fruit (1 avocado and 1 mango) compared to a control arm matched in calories (but not macronutrients or fiber) equivalent to 1 fresh Hass avocado + 1 cup of mango per day. Participants will be given general meal plans, including specific foods assnacks or meals to include in their diet daily.
- Pre-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 pre-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 pre-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.
- Information Session and Screening Session Information Session and Screening Visit may occur simultaneously or Information Session may occur prior to Screening Visit. Prior to the Screening Visit, potential subjects will be asked to arrive at the CNRC after an overnight-fast (stop eating after 10 pm) and be well-hydrated. Subjects should aim for drinking at least 8-10 cups of water the 24 h prior to the Screening Visit.
Information Session: At the CNRC, pre-screened subjects will participate in an Information Session where they will be informed of all study procedures and study schedules. If willing to adhere to all study procedures and schedules, they will be asked to read, ask questions, signand date the Institutional Review Board (IRB) approved Informed Consent Form (ICF) before any laboratory or study screening procedures begin.
Screening Visit: After meeting eligibility criteria for blood glucose (BG) and blood pressure (BP) measures, subjects will advance to further screening procedures which will include a comprehensive chemistry panel plus TSH, anthropometric measurements (height, weight, waist circumference, body composition), BMI (calculated from height and weight), medical history, prior and concomitant medication, and dietary supplements use, and completion of a series of questionnaires relating to their general health and lifestyle.
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)
盲法说明
Four one-week meal plans for each Active and Control intervention will be developed and given twice in random order to allow for a partially controlled dietary regimen.
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
- 是
入选标准
- •Men or women, age 25-70 year- 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 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
- •Abnormal Thyroid-stimulating Hormone (TSH) at screening visit
- •Men and women with diabetes
- •History of 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.
- •High refractive error (+/- 6.00 D, axial length greater than 26 mm or less than 22mm), astigmatism >3.00D, impaired vision/not correctible to 20/20, high eye pressures (>21 mmHg) and narrow angles (< grade 3 Van Herick) in the study eye as confirmed by screening eye exam at IEI screening visit
- •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)
研究组 & 干预措施
Avocado mango meal plan
2 meals and snacks per day, including 1 avocado + 1 cup of mango, covering 75% of daily calories needs,
干预措施: Meals + snacks: Avocado mango (Other)
Control meal plan
2 meals and snacks per day, without avocado and mango, covering 75% of daily calories needs
干预措施: Meals + snacks: control (Other)
结局指标
主要结局
Changes in Pulse Wave Velocity
时间窗: baseline-8 weeks
fasting state, Macro-vascular assessment by SphygmaCor technology:
Changes in Central Blood pressure
时间窗: baseline-8 weeks
fasting state, Macro-vascular assessment by SphygmaCor technology:
Changes in plasma biomarkers:lipid profile
时间窗: baseline-8 weeks
Randox automated clinical analyzer, total cholesterol,LDL cholesterol, HDL cholesterol, triglycerides
Changes in plasma biomarkers: fasting insulin
时间窗: baseline-8 weeks
Randox automated clinical analyzer
Changes in plasma biomarkers and measures of inflammation concentration: VCAM
时间窗: baseline-8 weeks
VCAM (ELISA, RnD systems)
Changes in plasma biomarkers:fasting glucose
时间窗: baseline-8 weeks
Randox automated clinical analyzer
Changes in plasma biomarkers and measures of inflammation concentration: ICAM
时间窗: baseline-8 weeks
ICAM (ELISA, RnD systems)
Changes in plasma biomarkers and measures of brain-derived neurotrophic factor: BDNF
时间窗: baseline-8 weeks
BDNF (ELISA, RnD systems)
Changes in Kidney function markers
时间窗: baseline-8 weeks
serum creatinine
Changes in vascular function measured by Flow-mediated vasodilation of brachial artery
时间窗: baseline-8 weeks
Macro-vascular assessment by Ultrasonography
Changes in plasma biomarkers and measures of inflammation concentration: IL-6
时间窗: baseline-8 weeks
IL-6 (ELISA, RnD systems)
Changes in plasma biomarkers and measures of brain-derived neurotrophic factor: IGF1
时间窗: baseline-8 weeks
IGF1 (ELISA, RnD systems)
次要结局
- Changes in Foveal Avascular Zone area(baseline-8 weeks)
- Changes in Cognitive Function-2(baseline-8 weeks)
- Changes in Vascular Density superficial and deep(baseline-8 weeks)
- Changes in Cognitive Function-3(baseline-8 weeks)
- Changes in Cognitive Function-5(baseline-8 weeks)
- Changes in Vascular branch number(baseline-8 weeks)
- Changes in Cognitive Function(baseline-8 weeks)
- Changes in Cognitive Function-6(baseline-8 weeks)
- Changes in Cognitive Function-1(baseline-8 weeks)
- Changes in Cognitive Function-4(baseline-8 weeks)