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

NCT05176197 | Unknown

• 1 other identifier: 055-055
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glucose Intolerance; Glucose Metabolism Disorders (Including Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

• HbA1c

  Baseline

• Change in HbA1c

  HbA1c % change

  16 weeks

Secondary Outcomes (7)

• Glucose response to a meal tolerance test

  Baseline and week 16

• Insulin response to a meal tolerance test

  Baseline and week 16

• Chronic glycemia

  Baseline, week 8 and week 16

• Food intake

  Two days (one week day and one weekend day) at screening, week 8 and week 16.

• Body weight

  Screening, baseline, week 4, week 8, week 12, and week 16

Other Outcomes (2)

• Compliance - Vitamin E

  Baseline, week 8 and week 16.

• Compliance - fatty acid profile

  Baseline, week 8 and week 16

Study Arms (2)

Almond Group

EXPERIMENTAL

Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.

Other: Almond

Control Group

EXPERIMENTAL

Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.

Other: Control

Interventions

Almond OTHER

Participants will consume almonds every day for 16 weeks.

Almond Group

Control OTHER

Participants will consume pretzels every day for 16 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HbA1c within normal range
• BMI \<20 kg/M\^2
• Nut allergies
• Smoker
• Pregnant

Sponsors & Collaborators

• Purdue University: lead
• Almond Board of California: collaborator

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Hyperglycemia; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Richard D Mattes, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nutrition Sciences

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 4, 2022
• Study Start: February 9, 2022
• Primary Completion: July 30, 2023
• Study Completion: May 30, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)