Clinical trial NCT05176197: Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
Official title: Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glucose Intolerance
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2022-01-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline
measure: Change in HbA1c
timeFrame: 16 weeks
Secondary outcomes:
measure: Glucose response to a meal tolerance test
timeFrame: Baseline and week 16
measure: Insulin response to a meal tolerance test
timeFrame: Baseline and week 16
measure: Chronic glycemia
timeFrame: Baseline, week 8 and week 16
measure: Food intake
timeFrame: Two days (one week day and one weekend day) at screening, week 8 and week 16.
measure: Body weight
timeFrame: Screening, baseline, week 4, week 8, week 12, and week 16
measure: Body composition
timeFrame: Baseline, week 16
measure: Hedonic survey
timeFrame: Baseline, week 4, week 8, week 12. week 16
Other outcomes:
measure: Compliance - Vitamin E
timeFrame: Baseline, week 8 and week 16.
measure: Compliance - fatty acid profile
timeFrame: Baseline, week 8 and week 16
Locations:
city: West Lafayette
country: United States
facility: Purdue Univeristy
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References: