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Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations

NCT ID: NCT05176197

Last Updated: 2023-12-12

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2024-05-30

Brief Summary

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This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.

Detailed Description

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Globally, it is projected that 418 million people will have impaired glucose tolerance by 2025. In the US, an estimated 34 million Americans have diabetes and 88 million, 33% of adults, have pre-diabetes. Impaired glucose tolerance is now manifesting in young adults where 20% of those 12-18 years of age have prediabetes. The current prevalence of Type 2 diabetes is over 8%, but it is projected that up to a third of Americans will develop diabetes in their lifetime. Additionally, the total annual cost of diabetes is approximately $327 which accounts for 25% of all US health care costs. Moreover, the costs rose 60% from 2007 to 2017 and this trend is continuing.

Diet is the preferred approach for management for this diet-related chronic disorder. Accumulating evidence suggests almond consumption decreases postprandial glycemia and may evoke a second meal effect, especially when they are consumed at breakfast or as an afternoon snack, which may aid in long-term glycemic control. Additionally, almond consumption can decrease total and LDL cholesterol, resulting in lower peripheral insulin resistance and cardiometabolic complications from type 2 diabetes mellitus. However, there is mixed evidence on the effects of almond consumption on HbA1c, a clinically important endpoint that provides a reliable measure of long-term glycemia and is correlated with risk of complications from diabetes. Thus, the investigators hypothesize a beneficial effect of regular almond consumption on long-term glycemic control in individuals with elevated baseline HbA1c.

Conditions

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Glucose Intolerance Glucose Metabolism Disorders (Including Diabetes Mellitus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Almond Group

Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.

Group Type EXPERIMENTAL

Almond

Intervention Type OTHER

Participants will consume almonds every day for 16 weeks.

Control Group

Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

Participants will consume pretzels every day for 16 weeks.

Interventions

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Almond

Participants will consume almonds every day for 16 weeks.

Intervention Type OTHER

Control

Participants will consume pretzels every day for 16 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HbA1c \>5.7%
* BMI \>20 kg/M\^2
* Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same level for the duration of the trial.
* Healthy, good dentition
* No nut allergies
* \>4.0 eating events per day
* \>=1 low nutrient density snack/d
* No allergy to chocolate

Exclusion Criteria

* HbA1c within normal range
* BMI \<20 kg/M\^2
* Nut allergies
* Smoker
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almond Board of California

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Richard Mattes

Professor, Nutrition Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard D Mattes, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue Univeristy

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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055-055

Identifier Type: -

Identifier Source: org_study_id