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The Effects of Including Almonds in a Weight Loss Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Richard Mattes, Purdue University
ClinicalTrials.gov Identifier:
NCT02360787
First received: November 20, 2014
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Overweight Obesity Behavioral: Energy restriction Behavioral: Almonds (15% kcal/day)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Including Almonds in an Energy-restricted Diet on Weight, Abdominal Fat Loss, Blood Pressure, and Cognitive Function

Resource links provided by NLM:


Further study details as provided by Richard Mattes, Purdue University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: August 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02360787

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Almond Board of California
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Mattes, Distinguished Professor Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT02360787     History of Changes
Other Study ID Numbers: 055-030
Study First Received: November 20, 2014
Last Updated: July 13, 2017

Keywords provided by Richard Mattes, Purdue University:
Almonds
Energy restriction
Obesity
Body weight
Body fat
Blood pressure
Cognitive function

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017