The Effects of Including Almonds in a Weight Loss Trial

January 16, 2018 updated by: Richard Mattes, Purdue University

The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • 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
      • West Lafayette, Indiana, United States, 47907
        • 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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult participants

  • Overweight or obese (BMI 25-40 kg/m2)
  • Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
  • No nut allergies
  • Willing to comply to study protocol and to eat test meals

Exclusion Criteria:

Those not meeting inclusion criteria.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Energy restriction
Energy restriction (-500 kcal/day) (N=40), where participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits to support weight loss. Participants will also be asked to avoid all nuts during the intervention period.
Behavioral: Energy restriction
Experimental: Energy restriction with almonds
Energy restriction (-500 kcal/day) with dry-roasted, lightly salted almonds supplying 15% of estimated energy requirement. Participants will receive dietary counseling to reduce energy intake to achieve 500 kcal/day deficits. Energy from almonds will be accounted for during dietary modeling so that a 500 kcal/day deficit is achieved.
Behavioral: Energy restriction
Behavioral: Almonds (15% kcal/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measurements
Time Frame: 12 weeks
Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks
12 weeks
Blood pressure
Time Frame: 12 weeks
Blood pressure measurements assessed at baseline, week-4, week-8 and week-12
12 weeks
Post-lunch cognitive function
Time Frame: 12 weeks
Cognitive function assessments will be performed after a standard lunch at baseline and week 12
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood biochemistries
Time Frame: 12 weeks
Fasting glucose, insulin, lipids and vitamin E over 12 weeks
12 weeks
Dietary intake
Time Frame: 10 weeks
Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10
10 weeks
Appetite ratings
Time Frame: 12 weeks
Appetite ratings assessed at baseline, week-4, week-8 and week-12
12 weeks
Physical activity
Time Frame: 12 weeks
Physical activity assessed at baseline, week-4, week-8 and week-12
12 weeks

Collaborators and Investigators

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

Sponsor

Purdue University

Collaborators

Almond Board of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055-030

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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