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

August 14, 2017 updated by: ICAN Nutrition Education and Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07327
        • ICAN Nutrition Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of body fat percentages from baseline
Time Frame: week 8
week 8
Changes of blood lipid profiles from baseline
Time Frame: week 8
week 8
Changes of body fat percentages from baseline
Time Frame: week 16
week 16
Changes of blood lipid profiles from baseline
Time Frame: week 16
week 16
Changes of body fat percentages from baseline
Time Frame: week 20
week 20
Changes of blood lipid profiles from baseline
Time Frame: week 20
week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of blood IL-6 levels
Time Frame: week 8
week 8
Changes of blood IL-6 levels
Time Frame: week 16
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICAN Nutrition Education and Research

Collaborators

Almond Board of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14-KIMH-01-ICAN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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