NCT03014531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

December 25, 2016

Last Update Submit

August 14, 2017

Conditions

Outcome Measures

Primary Outcomes (6)

  • Changes of body fat percentages from baseline

    week 8

  • Changes of blood lipid profiles from baseline

    week 8

  • Changes of body fat percentages from baseline

    week 16

  • Changes of blood lipid profiles from baseline

    week 16

  • Changes of body fat percentages from baseline

    week 20

  • Changes of blood lipid profiles from baseline

    week 20

Secondary Outcomes (2)

  • Changes of blood IL-6 levels

    week 8

  • Changes of blood IL-6 levels

    week 16

Study Arms (2)

almond

EXPERIMENTAL

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

OTHER

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

almondOTHER
almond
high-carbohydrate control food item

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICAN Nutrition Education and Research

Seoul, 07327, South Korea

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2016

First Posted

January 9, 2017

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations