The Effects of Including Almonds in a Weight Loss Trial

• ClinicalTrials.gov Identifier: NCT02360787
• Recruitment Status: Completed
• First Posted: February 11, 2015
• Last Update Posted: January 18, 2018
• Sponsor: Purdue University
• Collaborator: Almond Board of California
• Information provided by (Responsible Party): Richard Mattes, Purdue University

Tracking Information

• First Submitted Date: November 20, 2014
• First Posted Date: February 11, 2015
• Last Update Posted Date: January 18, 2018
• Actual Study Start Date: October 2012
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Overweight
• Obesity

Intervention

• Behavioral: Energy restriction
• Behavioral: Almonds (15% kcal/day)

Study Arms

• 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 *

• 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.
• 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. Epub 2016 Nov 2.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 5, 2015): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2017
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02360787
• Other Study ID Numbers: 055-030
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Richard Mattes, Purdue University
• Study Sponsor: Purdue University
• Collaborators: Almond Board of California
• Investigators: Not Provided
• PRS Account: Purdue University
• Verification Date: January 2018