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

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ClinicalTrials.gov Identifier: NCT01690936
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : May 30, 2013
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Dietary Supplement: Almonds 43g/day Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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.
Study Start Date : October 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

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

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

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


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

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


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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

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

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 Posted: September 24, 2012    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

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