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

This study has been completed.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Purdue University
ClinicalTrials.gov Identifier:
NCT01690936
First received: September 12, 2012
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Postprandial glucose, insulin and lipids [ Time Frame: 490 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in body weight, BMI, fat mass, waist circumference over 4 weeks

  • Fasting blood biochemistries [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4

  • Dietary intake [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Dietary intakes were assessed at baseline, week-2, and week-4 of study


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Baseline and week-4 ] [ Designated as safety issue: No ]
    Blood pressure measurements at baseline and final week of study

  • Appetite ratings [ Time Frame: Baseline, week-2, and week-4 ] [ Designated as safety issue: No ]
  • Postprandial appetite sensations [ Time Frame: 490 minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Purdue University
ClinicalTrials.gov Identifier: NCT01690936     History of Changes
Other Study ID Numbers: 055-022, Snacking study
Study First Received: September 12, 2012
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Almonds
Body weight
Snacking

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013