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Continuous Glucose Monitoring and Hass Avocado Trial ("CHAT")

NCT ID: NCT05293340

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-01-31

Brief Summary

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Hispanic/Latino adults in the United States (U.S.) bear a disproportionate burden of type 2 diabetes (T2D). Dietary changes, facilitated by increased access and adherence to healthy foods, are necessary. In this study, continuous glucose monitoring (CGM) will be used to quantify changes in glycemic control in Hispanic/Latino (predominantly of Mexican origin) adults with or at-risk of T2D before and after receiving free avocados for 12 weeks. Beyond CGM-measured glycemic control, wearable activity and sleep monitors, physical exams, laboratory analyses, and questionnaires/logs will be used to track the impact of free avocado vouchers. The findings are anticipated to help clinicians provide new information to support positive behavior change to reduce the risk of T2D or progression from pre-diabetes to T2D and make it easier for patients to access healthier food, potentially leading to improved health.

Detailed Description

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In this study, continuous glucose monitoring (CGM) will be used to quantify changes in glycemic control in Hispanic/Latino adults with and at-risk of T2D before and after receiving free avocado vouchers. The impact of using CGM to determine the effect of improving access to avocados on glycemic profiles and food related-behaviors for Hispanic/Latino adults with or at risk of T2D is not known at present. To address this need, increased avocado consumption will be combined with CGM to assess post-prandial glucose responses. This is based on evidence showing that one half of a Hass avocado at lunch is associated with increased satisfaction and reduced desire to eat over the subsequent 3-5 hours in overweight or obese adults.

For CGM, there is a lack of prospective data on the relationship between derived metrics and complications for adults with non-insulin treated T2D or at-risk of T2D, but glucose profiles from non-diabetic subjects suggest very tight glycemic control, with only brief postprandial excursions \>140 mg/dL. Cross-sectional data suggests more time spent between 140 and 180 mg/dl comparing predominantly Mexican American adults at risk of T2D to adults with pre-T2D and to adults with diagnosed T2D. Further, in a study examining the thresholds for CGM at which vascular disease can be detected, Lu and colleagues reported time in ranges above 140 mg/dL was associated with abnormal values for retinopathy and carotid intima-medial thickness, a measure of macrovascular disease risk. Hence, the focus in this study will be time in range between 140 and 180 mg/dl between 6 am and 12 am (waking hours).

Conditions

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Dietary Habits Diabetes Mellitus, Type 2

Keywords

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Glycemic control Minority Health Plants, Edible Food prescriptions Food security Time in Range

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will consist of two groups into which participants will be randomly assigned 1:1. One (active) group will receive vouchers for free avocados. The other (control) group will not receive avocado vouchers (to control for the impact of seasonal changes on diet that are outside the influence of the trial).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hispanic/Latino adults with or at risk of T2D- Active Group

Eligible participants receive vouchers for free avocados.

Group Type EXPERIMENTAL

Avocado Vouchers

Intervention Type DIETARY_SUPPLEMENT

Food as Medicine to demonstrate clinically meaningful benefits for underserved communities. Avocados are fruits with fats, fiber, micronutrients, and bioactive phytochemicals.

Hispanic/Latino adults with or at risk of T2D- Control Group

Eligible participants will not receive vouchers for free avocados.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Avocado Vouchers

Food as Medicine to demonstrate clinically meaningful benefits for underserved communities. Avocados are fruits with fats, fiber, micronutrients, and bioactive phytochemicals.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Adults ≥ 18 years of age at enrollment.
2. Self-reported Hispanic/Latino heritage.
3. Self-reported diagnosis of T2D or self-reported as at risk for developing T2D using the American Diabetes Association diabetes risk assessment tool \[25\].

Exclusion Criteria

1. Use of insulin
2. Pregnancy
3. Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hass Avocado Board

OTHER

Sponsor Role collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Kerr, MBChB

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

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Sansum Diabetes Research Institute

Santa Barbara, California, United States

Site Status

Countries

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United States

Other Identifiers

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C2021-0068

Identifier Type: -

Identifier Source: org_study_id