NCT03236116

Brief Summary

This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

July 13, 2017

Last Update Submit

January 6, 2021

Conditions

Glucose IntoleranceAppetite DisordersGlucose Metabolism Disorders (Including Diabetes Mellitus)Lipid Metabolism Disorder

Outcome Measures

Primary Outcomes (27)

  • HbA1c

    HbA1c.

    Baseline

  • fasting glucose

    fasting glucose,

    Baseline

  • fasting triglycerides

    fasting triglycerides

    Baseline

  • Change in Body weight

    Body weight

    Every two weeks for 6 months.

  • Body composition

    Body composition

    Baseline

  • GLP-1

    GLP-1

    Baseline

  • Change in HbA1c

    HbA1c.

    6 months

  • Change in fasting glucose

    fasting glucose

    6 months

  • fasting triglycerides

    fasting triglycerides

    6 months

  • Change in Body composition

    Body composition

    6 months

  • Change in GLP-1

    GLP-1

    6 months

  • fasting insulin

    fasting insulin

    Baseline

  • total cholesterol

    total cholesterol

    Baseline

  • LDL-cholesterol

    LDL-cholesterol

    Baseline

  • HDL-cholesterol

    HDL-cholesterol

    Baseline

  • GIP

    GIP

    Baseline

  • change in fasting insulin

    fasting insulin

    6 months

  • change in total cholesterol

    total cholesterol

    6 months

  • change in LDL-cholesterol

    LDL-cholesterol

    6 months

  • change in HDL-cholesterol

    HDL-cholesterol

    6 months

  • change in GIP

    GIP

    6 months

  • C-peptide

    baseline

  • C-peptide

    6 months

  • Homa-IR

    baseline

  • Homa-IR

    6 months

  • Homa-Percent Beta

    Baseline

  • Homa-Percent Beta

    6 months

Secondary Outcomes (2)

  • Diet Quality

    Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.

  • Compliance

    Baseline, month 2, 4, and 6.

Study Arms (2)

Almond Group

EXPERIMENTAL

Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.

Other: Almonds

Control Group

EXPERIMENTAL

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)

Interventions

AlmondsOTHER

Participants will consume almonds everyday for 6 months.

Almond Group
Control (no nuts)OTHER

Participants will not be permited to consume any nuts for 6 months.

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • years
  • no nut allergies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Purdue University

West Lafayette, Indiana, 47909, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceFeeding and Eating DisordersGlucose Metabolism DisordersLipid Metabolism Disorders

Condition Hierarchy (Ancestors)

HyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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

July 13, 2017

First Posted

August 1, 2017

Study Start

August 1, 2017

Primary Completion

March 20, 2020

Study Completion

December 31, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)