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

Purdue University

Status: Active, not recruiting

Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus); Glucose Intolerance

Treatments: Other: Control; Other: Almond

Study type: Interventional

Funder types: Other

Identifiers

NCT05176197

055-055

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Almond Group

Experimental group

Description:

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

Treatment:

Other: Almond

Control Group

Experimental group

Description:

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

Treatment:

Other: Control