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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05176197
Other study ID # 055-055
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 9, 2022
Est. completion date May 30, 2024

Study information

Verified date December 2023
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date May 30, 2024
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Almond
Participants will consume almonds every day for 16 weeks.
Control
Participants will consume pretzels every day for 16 weeks.

Locations

Country Name City State
United States Purdue Univeristy West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Compliance - Vitamin E mg/L Baseline, week 8 and week 16.
Other Compliance - fatty acid profile % fatty acid composition Baseline, week 8 and week 16
Primary HbA1c Baseline
Primary Change in HbA1c HbA1c % change 16 weeks
Secondary Glucose response to a meal tolerance test mg/dl Baseline and week 16
Secondary Insulin response to a meal tolerance test mmol/L Baseline and week 16
Secondary Chronic glycemia mg/dl Baseline, week 8 and week 16
Secondary Food intake kcal Two days (one week day and one weekend day) at screening, week 8 and week 16.
Secondary Body weight Kilograms (kg) Screening, baseline, week 4, week 8, week 12, and week 16
Secondary Body composition Percentage (%) Baseline, week 16
Secondary Hedonic survey mm on a VAS Baseline, week 4, week 8, week 12. week 16
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