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

Not Applicable

Active, not recruiting

• Conditions: Glucose Intolerance; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Interventions: Other: Control; Other: Almond

• Registration Number: NCT05176197
• Lead Sponsor: Purdue University

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Study Start: 2022-02-09
• Primary Completion: 2023-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control	Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.
Almond Group	Almond	Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	16 weeks	HbA1c % change
HbA1c	Baseline

Secondary Outcome Measures

Name	Time	Method
Glucose response to a meal tolerance test	Baseline and week 16	mg/dl
Insulin response to a meal tolerance test	Baseline and week 16	mmol/L
Chronic glycemia	Baseline, week 8 and week 16	mg/dl
Hedonic survey	Baseline, week 4, week 8, week 12. week 16	mm on a VAS
Food intake	Two days (one week day and one weekend day) at screening, week 8 and week 16.	kcal
Body weight	Screening, baseline, week 4, week 8, week 12, and week 16	Kilograms (kg)
Body composition	Baseline, week 16	Percentage (%)

Trial Locations

Locations (1)

Purdue Univeristy; 🇺🇸 West Lafayette, Indiana, United States