Status:
ACTIVE_NOT_RECRUITING
Dietary Exchanges With Avocado and Mango in Pre-diabetes
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
Hass Avocado Board
National Mango Board
Conditions:
Pre Diabetes
Vascular Stiffness
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
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- vasc...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05353790
Start Date
October 11 2021
End Date
September 6 2025
Last Update
May 8 2025
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616