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OpenTrials
Completed

NCT Number: NCT03014531

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

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.

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Key information

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICAN Nutrition Education and Research

Seoul, 07327, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almond

Other

high-carbohydrate control food

Other

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

Sponsors and collaborators

Lead sponsor

ICAN Nutrition Education and Research

Industry

Collaborators

  • Almond Board of California

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2017
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.