Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Including Almonds in a Weight Loss Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02360787
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE February 11, 2015
Last Update Posted Date January 18, 2018
Actual Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • Anthropometric measurements [ Time Frame: 12 weeks ]
    Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks
  • Blood pressure [ Time Frame: 12 weeks ]
    Blood pressure measurements assessed at baseline, week-4, week-8 and week-12
  • Post-lunch cognitive function [ Time Frame: 12 weeks ]
    Cognitive function assessments will be performed after a standard lunch at baseline and week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • Fasting blood biochemistries [ Time Frame: 12 weeks ]
    Fasting glucose, insulin, lipids and vitamin E over 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
  • Appetite ratings [ Time Frame: 12 weeks ]
    Appetite ratings assessed at baseline, week-4, week-8 and week-12
  • Physical activity [ Time Frame: 12 weeks ]
    Physical activity assessed at baseline, week-4, week-8 and week-12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Including Almonds in a Weight Loss Trial
Official Title  ICMJE The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Behavioral: Energy restriction
  • Behavioral: Almonds (15% kcal/day)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Interventions:
    • Behavioral: Energy restriction
    • Behavioral: Almonds (15% kcal/day)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 5, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02360787
Other Study ID Numbers  ICMJE 055-030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Mattes, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Almond Board of California
Investigators  ICMJE Not Provided
PRS Account Purdue University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP