The Effects of Including Almonds in a Weight Loss Trial

NCT ID: NCT02360787

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Energy restriction

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Energy restriction

Intervention Type BEHAVIORAL

Almonds (15% kcal/day)

Intervention Type BEHAVIORAL

Interventions

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Energy restriction

Intervention Type BEHAVIORAL

Almonds (15% kcal/day)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almond Board of California

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Richard Mattes

Distinguished Professor Nutrition Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Dhillon J, Ferreira CR, Sobreira TJP, Mattes RD. Multiple Reaction Monitoring Profiling to Assess Compliance with an Almond Consumption Intervention. Curr Dev Nutr. 2017 Sep 6;1(9):e001545. doi: 10.3945/cdn.117.001545. eCollection 2017 Sep.

Reference Type DERIVED
PMID: 29955720 (View on PubMed)

Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.

Reference Type DERIVED
PMID: 27807041 (View on PubMed)

Other Identifiers

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055-030

Identifier Type: -

Identifier Source: org_study_id

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