Avocado Snacks in a Prediabetic Population

NCT05263011 | Completed

• 1 other identifier: IRB-2021-81
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PreDiabetes

Keywords

avocado

Outcome Measures

Primary Outcomes (5)

• Changes in plasma glucose concentration

  will be analyzed by a Randox automated clinical analyzer

  time 0-180 minutes

• Changes in plasma insulin concentration

  will be analyzed by a Randox automated clinical analyzer

  time 0-180 minutes

• Changes in plasma triglycerides concentration

  will be analyzed by a Randox automated clinical analyzer

  time 0-180 minutes

• Changes in plasma Interleukin (IL)-6 concentration

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

  time 0-3 hours

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

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

  time 0-3 hours

Study Arms (3)

Avocado snack

EXPERIMENTAL

1 avocado

Other: Avocado

control snack + fiber supplement + vegetable oil

PLACEBO COMPARATOR

high fat, high fiber control

Other: low fat yogurt + fiber +fat

control snack

OTHER

Low-fiber, low-fat

Other: low fat yogurt

Interventions

Avocado OTHER

1 avocado as evening snack

Avocado snack

low fat yogurt OTHER

1 serving of low fat yogurt matching calories of 1 avocado

control snack

low fat yogurt + fiber +fat OTHER

low fat yogurt mixed with ultra processed olive oil + fiber supplement, equivalent to fat and fiber content in 1 avocado

control snack + fiber supplement + vegetable oil

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 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

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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Preiss C, Marquis O, Edirisinghe I, Burton-Freeman BM. Using the Avocado as an Evening Snack to Investigate Whole Food Matrix and Macronutrient Composition on Morning Metabolic Indices in Adults With Prediabetes. Curr Dev Nutr. 2025 Jun 12;9(7):107486. doi: 10.1016/j.cdnut.2025.107486. eCollection 2025 Jul.

  PMID: 40689342 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Britt Burton-Freeman, ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: June 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: April 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)