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Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults

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ClinicalTrials.gov Identifier: NCT03014531
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
ICAN Nutrition Education and Research

Brief Summary:
The study was conducted to investigate the effects of daily almond intake based on the timing of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body composition, lipid profile, and oxidative and inflammation indicators among young Korean adults.

Condition or disease Intervention/treatment Phase
Adult Young and Healthy Other: almond Other: high-carbohydrate control food Not Applicable

Detailed Description:
The current study was conducted to investigate the effects of daily almond intake on body composition, lipid profile, and oxidative and inflammation indicators among young Korean adults based on the timing of almond consumption. Participants were randomly assigned to one of three groups: (1) a pre-meal group (PM; n = 58) in which participants were instructed to consume 56 g of almonds per day as a preload when having regular meals; (2) a snack group (SN; n =55) in which participants were instructed to consume 56 g of almonds between meals as snacks; and (3) a control group (CL; n = 56) in which participants were provided high-carbohydrate iso-caloric control food. The three-day diet records, including two consecutive weekdays and one weekend day, were done once before the trial and twice during the trial. Body composition was assessed through multi-frequency whole-body bioimpedance measurement using InBody 620 (Biospace Co., Ltd, Seoul, Korea).After a 12-hour fast, blood samples were taken at the baseline time point (week 0) and at weeks 8 and 16 by standard venipuncture. The serum total cholesterol and triglycerides levels were measured by the enzymatic-colorimetric method using a Cobas 8000 c702 chemistry analyzer (Roche Diagnostics; Mannheim, Germany). HDL cholesterol and LDL cholesterol levels were determined via homogeneous enzymatic colorimetry.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Almond Intake as a Preload Before Meals Versus as a Snack Between Meals Has Different Effects on Body Fat Percentages and the Lipid Profile in a Randomized Controlled Trial of Young Adults in South Korea
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: almond
In this group, participants were provided with 56 g of almonds per day either as preload before meals or snack between meals. A snack was defined as an eating event that occurred between participants' regular meals, specifically two hours before and after meals. All the participants in almond group were provided daily portions of packaged almonds.
Other: almond
high-carbohydrate control food item
In this group, participants were provided with high-carbohydrate control food item that had a similar number of calories as 56 g of almonds.
Other: high-carbohydrate control food



Primary Outcome Measures :
  1. Changes of body fat percentages from baseline [ Time Frame: week 8 ]
  2. Changes of blood lipid profiles from baseline [ Time Frame: week 8 ]
  3. Changes of body fat percentages from baseline [ Time Frame: week 16 ]
  4. Changes of blood lipid profiles from baseline [ Time Frame: week 16 ]
  5. Changes of body fat percentages from baseline [ Time Frame: week 20 ]
  6. Changes of blood lipid profiles from baseline [ Time Frame: week 20 ]

Secondary Outcome Measures :
  1. Changes of blood IL-6 levels [ Time Frame: week 8 ]
  2. Changes of blood IL-6 levels [ Time Frame: week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-smokers
  • age 20-39 yr
  • Male and Female non-smokers
  • BMI 17-30 kg/m2
  • under Korean habitual diet

Exclusion criteria:

  • any diseases
  • any weight change 6 mo before the study
  • >2 times/wk nut consumption
  • frequent alcohol consumption
  • any use of nutrient supplements
  • erratic exercise habits
  • women who were with irregular menses, taking birth control pills, pregnant or lactating

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): NCT03014531


Locations
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Korea, Republic of
ICAN Nutrition Education and Research
Seoul, Korea, Republic of, 07327
Sponsors and Collaborators
ICAN Nutrition Education and Research
Almond Board of California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ICAN Nutrition Education and Research
ClinicalTrials.gov Identifier: NCT03014531    
Other Study ID Numbers: 14-KIMH-01-ICAN
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017