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The Effects of Including Almonds in a Weight Loss Trial

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy restriction
Almonds (15% kcal/day)
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Almonds, Energy restriction, Obesity, Body weight, Body fat, Blood pressure, Cognitive function

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Energy restriction

Energy restriction with almonds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2014
Last Updated
January 16, 2018
Sponsor
Purdue University
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT02360787
Brief Title
The Effects of Including Almonds in a Weight Loss Trial
Official Title
The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Almonds, Energy restriction, Obesity, Body weight, Body fat, Blood pressure, Cognitive function

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Energy restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Energy restriction with almonds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Energy restriction
Intervention Type
Behavioral
Intervention Name(s)
Almonds (15% kcal/day)
Primary Outcome Measure Information:
Title
Anthropometric measurements
Description
Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks
Time Frame
12 weeks
Title
Blood pressure
Description
Blood pressure measurements assessed at baseline, week-4, week-8 and week-12
Time Frame
12 weeks
Title
Post-lunch cognitive function
Description
Cognitive function assessments will be performed after a standard lunch at baseline and week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting blood biochemistries
Description
Fasting glucose, insulin, lipids and vitamin E over 12 weeks
Time Frame
12 weeks
Title
Dietary intake
Description
Dietary intakes assessed at baseline, week-1, week-2, week-3, week-4, week-6, week-8 and week-10
Time Frame
10 weeks
Title
Appetite ratings
Description
Appetite ratings assessed at baseline, week-4, week-8 and week-12
Time Frame
12 weeks
Title
Physical activity
Description
Physical activity assessed at baseline, week-4, week-8 and week-12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29955720
Citation
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.
Results Reference
derived
PubMed Identifier
27807041
Citation
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.
Results Reference
derived

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The Effects of Including Almonds in a Weight Loss Trial

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