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The Effects of Including Almonds in a Weight Loss Trial

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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

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Energy restriction Behavioral: Almonds (15% kcal/day) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Actual Study Start Date : October 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Anthropometric measurements [ Time Frame: 12 weeks ]
    Changes in body weight, BMI, fat mass, waist circumference and abdominal height over 12 weeks

  2. Blood pressure [ Time Frame: 12 weeks ]
    Blood pressure measurements assessed at baseline, week-4, week-8 and week-12

  3. 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 :
  1. Fasting blood biochemistries [ Time Frame: 12 weeks ]
    Fasting glucose, insulin, lipids and vitamin E over 12 weeks

  2. 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

  3. Appetite ratings [ Time Frame: 12 weeks ]
    Appetite ratings assessed at baseline, week-4, week-8 and week-12

  4. Physical activity [ Time Frame: 12 weeks ]
    Physical activity assessed at baseline, week-4, week-8 and week-12



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360787


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Almond Board of California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Mattes, Distinguished Professor Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT02360787    
Other Study ID Numbers: 055-030
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Richard Mattes, Purdue University:
Almonds
Energy restriction
Obesity
Body weight
Body fat
Blood pressure
Cognitive function
Additional relevant MeSH terms:
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Overweight
Body Weight