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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05176197
• Other study ID #: 055-055
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Metabolic Diseases

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