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

Study Overview
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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.

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

Conditions
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Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)

Intervention / Treatment
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* Other: Almond
* Other: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond Group<br>Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. | Other: Almond<br>* Participants will consume almonds every day for 16 weeks.<br>|
| Experimental: Control Group<br>Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. | Other: Control<br>* Participants will consume pretzels every day for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Baseline | 
| Change in HbA1c | HbA1c % change | 16 weeks | 

Secondary Outcome Measures

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