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

• Sponsor: Purdue University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05176197
• Collaborator: Almond Board of California (Other)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.7
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glucose Intolerance; Glucose Metabolism Disorders (Including Diabetes Mellitus)	Other: Almond; Other: Control	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
• Actual Study Start Date: Feb 9, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HbA1c [Baseline]

2. Change in HbA1c [16 weeks]

   HbA1c % change

Secondary Outcome Measures

1. Glucose response to a meal tolerance test [Baseline and week 16]

   mg/dl

2. Insulin response to a meal tolerance test [Baseline and week 16]

   mmol/L

3. Chronic glycemia [Baseline, week 8 and week 16]

   mg/dl

4. Food intake [Two days (one week day and one weekend day) at screening, week 8 and week 16.]

   kcal

5. Body weight [Screening, baseline, week 4, week 8, week 12, and week 16]

   Kilograms (kg)

6. Body composition [Baseline, week 16]

   Percentage (%)

7. Hedonic survey [Baseline, week 4, week 8, week 12. week 16]

   mm on a VAS

Other Outcome Measures

1. Compliance - Vitamin E [Baseline, week 8 and week 16.]

   mg/L

2. Compliance - fatty acid profile [Baseline, week 8 and week 16]

   % fatty acid composition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• HbA1c >5.7 and <7.1%

• BMI 25-35 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 <25 or >35 kg/M^2

• Nut allergies

• Smoker

• Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue Univeristy	West Lafayette	Indiana	United States	47907

Sponsors and Collaborators

• Purdue University
• Almond Board of California

Investigators

• Principal Investigator: Richard D Mattes, PhD, Purdue University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Mattes, Professor, Nutrition Sciences, Purdue University
• ClinicalTrials.gov Identifier: NCT05176197
• Other Study ID Numbers: 055-055
• First Posted: Jan 4, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Glucose Intolerance

Study Results

No Results Posted as of Apr 19, 2022