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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    84
  • sponsor
    Purdue University
Updated on 15 June 2022
Accepts healthy volunteers

Summary

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

Description

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.

Details
Condition Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Treatment Control, Almond
Clinical Study IdentifierNCT05176197
SponsorPurdue University
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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 allergy to chocolate

Exclusion Criteria

BMI <20 kg/M^2
HbA1c within normal range
Nut allergies
Smoker
Pregnant
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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