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

Primary Purpose

Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almond
Control
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Purdue Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Almond Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c
Change in HbA1c
HbA1c % change

Secondary Outcome Measures

Glucose response to a meal tolerance test
mg/dl
Insulin response to a meal tolerance test
mmol/L
Chronic glycemia
mg/dl
Food intake
kcal
Body weight
Kilograms (kg)
Body composition
Percentage (%)
Hedonic survey
mm on a VAS

Full Information

First Posted
November 23, 2021
Last Updated
March 28, 2023
Sponsor
Purdue University
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT05176197
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Almond Board of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almond Group
Arm Type
Experimental
Arm Description
Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products.
Intervention Type
Other
Intervention Name(s)
Almond
Intervention Description
Participants will consume almonds every day for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will consume pretzels every day for 16 weeks.
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
Baseline
Title
Change in HbA1c
Description
HbA1c % change
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Glucose response to a meal tolerance test
Description
mg/dl
Time Frame
Baseline and week 16
Title
Insulin response to a meal tolerance test
Description
mmol/L
Time Frame
Baseline and week 16
Title
Chronic glycemia
Description
mg/dl
Time Frame
Baseline, week 8 and week 16
Title
Food intake
Description
kcal
Time Frame
Two days (one week day and one weekend day) at screening, week 8 and week 16.
Title
Body weight
Description
Kilograms (kg)
Time Frame
Screening, baseline, week 4, week 8, week 12, and week 16
Title
Body composition
Description
Percentage (%)
Time Frame
Baseline, week 16
Title
Hedonic survey
Description
mm on a VAS
Time Frame
Baseline, week 4, week 8, week 12. week 16
Other Pre-specified Outcome Measures:
Title
Compliance - Vitamin E
Description
mg/L
Time Frame
Baseline, week 8 and week 16.
Title
Compliance - fatty acid profile
Description
% fatty acid composition
Time Frame
Baseline, week 8 and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Mattes, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue Univeristy
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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