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CompletedNCT03014531Updated Aug 16, 2017

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

An interventional study of almond and high-carbohydrate control food in Adult Young and Healthy, sponsored by ICAN Nutrition Education and Research. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by ICAN Nutrition Education and Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
227
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adult Young and Healthy
03

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
227 participants (actual)

Study arms

  • 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

Interventions

  • Otheralmond
  • Otherhigh-carbohydrate control food
05

What researchers measure

Primary outcomes

  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 outcomes

  1. Changes of blood IL-6 levels

    Time frame: week 8

  2. Changes of blood IL-6 levels

    Time frame: week 16

06

Study locations

1 site
  • ICAN Nutrition Education and Research
    Seoul, 07327, Korea, Republic of
07

References and documents

Publications

  • Liu Y, Hwang HJ, Ryu H, Lee YS, Kim HS, Park H. The effects of daily intake timing of almond on the body composition and blood lipid profile of healthy adults. Nutr Res Pract. 2017 Dec;11(6):479-486. doi: 10.4162/nrp.2017.11.6.479. Epub 2017 Nov 22. PubMed 29209458 ↗
08

Registry details

Key details

Study ID
NCT03014531
Lead sponsor
ICAN Nutrition Education and Research
Collaborators
Almond Board of California
Responsible party
Sponsor
First posted
Jan 9, 2017
Start date
Jun 2014
Primary completion
May 2016
Completion
May 2016
Last update
Aug 16, 2017
View the source record on ClinicalTrials.gov ↗

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