Dietary Exchanges With Avocado and Mango in Pre-diabetes

NCT05353790 | Completed

• 1 other identifier: IRB-2021-67
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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- 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

Conditions

Pre Diabetes; Vascular Stiffness; Vascular Dilation; Cognitive Change; Retinal Vascular

Outcome Measures

Primary Outcomes (12)

• Changes in vascular function measured by Flow-mediated vasodilation of brachial artery

  Macro-vascular assessment by Ultrasonography

  baseline-8 weeks

• Changes in Pulse Wave Velocity

  fasting state, Macro-vascular assessment by SphygmaCor technology:

  baseline-8 weeks

• Changes in Central Blood pressure

  fasting state, Macro-vascular assessment by SphygmaCor technology:

  baseline-8 weeks

• Changes in plasma biomarkers:fasting glucose

  Randox automated clinical analyzer

  baseline-8 weeks

• Changes in plasma biomarkers: fasting insulin

  Randox automated clinical analyzer

  baseline-8 weeks

• Changes in plasma biomarkers:lipid profile

  Randox automated clinical analyzer, total cholesterol,LDL cholesterol, HDL cholesterol, triglycerides

  baseline-8 weeks

• Changes in plasma biomarkers and measures of inflammation concentration: IL-6

  IL-6 (ELISA, RnD systems)

  baseline-8 weeks

• Changes in plasma biomarkers and measures of inflammation concentration: ICAM

  ICAM (ELISA, RnD systems)

  baseline-8 weeks

• Changes in plasma biomarkers and measures of inflammation concentration: VCAM

  VCAM (ELISA, RnD systems)

  baseline-8 weeks

• Changes in plasma biomarkers and measures of brain-derived neurotrophic factor: BDNF

  BDNF (ELISA, RnD systems)

  baseline-8 weeks

• Changes in plasma biomarkers and measures of brain-derived neurotrophic factor: IGF1

  IGF1 (ELISA, RnD systems)

  baseline-8 weeks

• Changes in Kidney function markers

  serum creatinine

  baseline-8 weeks

Secondary Outcomes (10)

• Changes in Foveal Avascular Zone area

  baseline-8 weeks

• Changes in Vascular Density superficial and deep

  baseline-8 weeks

• Changes in Vascular branch number

  baseline-8 weeks

• Changes in Cognitive Function

  baseline-8 weeks

• Changes in Cognitive Function-1

  baseline-8 weeks

Study Arms (2)

Avocado mango meal plan

EXPERIMENTAL

2 meals and snacks per day, including 1 avocado + 1 cup of mango, covering 75% of daily calories needs,

Other: Meals + snacks: Avocado mango

Control meal plan

OTHER

2 meals and snacks per day, without avocado and mango, covering 75% of daily calories needs

Other: Meals + snacks: control

Interventions

Meals + snacks: control OTHER

8 weeks meal plans matched in calories (but not macronutrients or fiber) equivalent to 1 avocado + 1 cup of mango per day

Control meal plan

Meals + snacks: Avocado mango OTHER

8 weeks meal plans provide1 avocado + 1 cup of mango per day

Avocado mango meal plan

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Hass Avocado Board: collaborator
• National Mango Board: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Preiss C, Tunio S, Hirimuthugoda LK, Zoltoski R, Ellison RL, Sandhu AK, Edirisinghe I, Burton-Freeman BM. Effects of Increasing Total Fruit Intake With Avocado and Mango on Endothelial Function and Cardiometabolic Risk Factors in Adults With Prediabetes. J Am Heart Assoc. 2026 Feb 17;15(4):e040933. doi: 10.1161/JAHA.124.040933. Epub 2026 Feb 16.

  PMID: 41698896 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Meals

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: April 29, 2022
• Study Start: October 11, 2021
• Primary Completion: December 6, 2023
• Study Completion: December 20, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)