NCT05176197

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Purdue University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Glucose Intolerance
• Glucose Metabolism Disorders (Including Diabetes Mellitus)

Interventions

Type	Name	Description
OTHER	Almond	Participants will consume almonds every day for 16 weeks.
OTHER	Control	Participants will consume pretzels every day for 16 weeks.

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-07-30
• Completion: 2024-05-30
• First posted: 2022-01-04
• Last updated: 2023-12-12

Locations

1 site across 1 country: United States