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Metabolic Effects of Almond in the Longer-term Study (MEAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690936
First Posted: September 24, 2012
Last Update Posted: May 30, 2013
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.
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Richard Mattes, Purdue University
  Purpose
Identifying snacks that do not contribute to positive energy balance is crucial in weight management. The satiating effects of almonds, coupled with their convenience and palatability make them a promising weight management aid. Therefore, this study aimed to examine the effects of almond consumption with meals versus snacks on outcomes such as appetite, energy intake, body weight, as well as blood glucose, insulin and lipid responses.

Condition Intervention
Obesity Dietary Supplement: Almonds 43g/day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Chronic Almond Consumption at Meals or as Snacks on Appetite, Intake, Body Weight, Glycemia, Insulinemia and Lipids in Healthy Adults.

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

Primary Outcome Measures:
  • Postprandial glucose, insulin and lipids [ Time Frame: 490 minutes ]
    Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.

  • Anthropometric measurements [ Time Frame: 4 weeks ]
    Changes in body weight, BMI, fat mass, waist circumference over 4 weeks

  • Fasting blood biochemistries [ Time Frame: 4 weeks ]
    Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4

  • Dietary intake [ Time Frame: 4 weeks ]
    Dietary intakes were assessed at baseline, week-2, and week-4 of study


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Baseline and week-4 ]
    Blood pressure measurements at baseline and final week of study

  • Appetite ratings [ Time Frame: Baseline, week-2, and week-4 ]
  • Postprandial appetite sensations [ Time Frame: 490 minutes ]

Enrollment: 150
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breakfast
Almonds (43g/day) were consumed with breakfast for four weeks.
Dietary Supplement: Almonds 43g/day
43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
Experimental: Morning snack
Almonds (43g/day) were consumed alone as morning snacks for four weeks.
Dietary Supplement: Almonds 43g/day
43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
Experimental: Lunch
Almonds (43g/day) were consumed with lunch for four weeks.
Dietary Supplement: Almonds 43g/day
43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
Experimental: Afternoon snack
Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.
Dietary Supplement: Almonds 43g/day
43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
No Intervention: Control no nuts
Avoided all nuts and seeds

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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:

  • Not taking any medication known to affect glycemia, lipid metabolism or appetite
  • Regular breakfast consumers
  • Eat at least 5 meals a day
  • Weight stable
  • Either one of the 6 conditions
  • BMI 27-35
  • Family history of diabetes
  • Fasting glucose between 6.1-6.9 mmol/L
  • 2-hour glucose 7.8-11.1 mmol/L
  • blood pressure >130/85 mmHg
  • Waist >102cm (men) and >88cm (women)

Exclusion Criteria:

  • Nut allergy
  • Not willing to eat test foods and almonds
  Contacts and Locations
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): NCT01690936


Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Almond Board of California
Investigators
Principal Investigator: Richard D Mattes, PhD Purdue University
  More Information

Responsible Party: Richard Mattes, Distinguished Prof Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT01690936     History of Changes
Other Study ID Numbers: 055-022
Snacking study ( Other Grant/Funding Number: Almond Board of California )
First Submitted: September 12, 2012
First Posted: September 24, 2012
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Richard Mattes, Purdue University:
Almonds
Body weight
Snacking