Almond Consumption and Glycemia

January 6, 2021 updated by: Richard Mattes, Purdue University
This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.

Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • West Lafayette, Indiana, United States, 47907
        • Purdue University
      • West Lafayette, Indiana, United States, 47909
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
  • 18-60 years
  • no nut allergies

Exclusion Criteria:

  • Not meeting one of the body fat distribution criteria
  • allergic to nuts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Almond Group
Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.
Other: Almonds
Participants will consume almonds everyday for 6 months.
EXPERIMENTAL: Control Group
Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.
Other: Control (no nuts)
Participants will not be permited to consume any nuts for 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline
HbA1c.
Baseline
fasting glucose
Time Frame: Baseline
fasting glucose,
Baseline
fasting triglycerides
Time Frame: Baseline
fasting triglycerides
Baseline
Change in Body weight
Time Frame: Every two weeks for 6 months.
Body weight
Every two weeks for 6 months.
Body composition
Time Frame: Baseline
Body composition
Baseline
GLP-1
Time Frame: Baseline
GLP-1
Baseline
Change in HbA1c
Time Frame: 6 months
HbA1c.
6 months
Change in fasting glucose
Time Frame: 6 months
fasting glucose
6 months
fasting triglycerides
Time Frame: 6 months
fasting triglycerides
6 months
Change in Body composition
Time Frame: 6 months
Body composition
6 months
Change in GLP-1
Time Frame: 6 months
GLP-1
6 months
fasting insulin
Time Frame: Baseline
fasting insulin
Baseline
total cholesterol
Time Frame: Baseline
total cholesterol
Baseline
LDL-cholesterol
Time Frame: Baseline
LDL-cholesterol
Baseline
HDL-cholesterol
Time Frame: Baseline
HDL-cholesterol
Baseline
GIP
Time Frame: Baseline
GIP
Baseline
change in fasting insulin
Time Frame: 6 months
fasting insulin
6 months
change in total cholesterol
Time Frame: 6 months
total cholesterol
6 months
change in LDL-cholesterol
Time Frame: 6 months
LDL-cholesterol
6 months
change in HDL-cholesterol
Time Frame: 6 months
HDL-cholesterol
6 months
change in GIP
Time Frame: 6 months
GIP
6 months
C-peptide
Time Frame: baseline
baseline
C-peptide
Time Frame: 6 months
6 months
Homa-IR
Time Frame: baseline
baseline
Homa-IR
Time Frame: 6 months
6 months
Homa-Percent Beta
Time Frame: Baseline
Baseline
Homa-Percent Beta
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet Quality
Time Frame: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
Compliance
Time Frame: Baseline, month 2, 4, and 6.
Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
Baseline, month 2, 4, and 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Almond Board of California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 055-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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