Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Conditions
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.
Interventions
OTHERAlmond
Participants will consume almonds every day for 16 weeks.
OTHERControl
Participants will consume pretzels every day for 16 weeks.
Sponsors
Purdue University
Almond Board of California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline | — |
| Change in HbA1c | 16 weeks | HbA1c % change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin response to a meal tolerance test | Baseline and week 16 | mmol/L |
| Chronic glycemia | Baseline, week 8 and week 16 | mg/dl |
| Body weight | Screening, baseline, week 4, week 8, week 12, and week 16 | Kilograms (kg) |
| Body composition | Baseline, week 16 | Percentage (%) |
| 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 |
| Glucose response to a meal tolerance test | Baseline and week 16 | mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compliance - Vitamin E | Baseline, week 8 and week 16. | mg/L |
| Compliance - fatty acid profile | Baseline, week 8 and week 16 | % fatty acid composition |
Countries
United States
Outcome results
None listed