Clinical trial NCT03014531: Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Young and Healthy
Lead sponsor: ICAN Nutrition Education and Research
Sponsor class: INDUSTRY
Collaborators: name: Almond Board of California
First posted: 2017-01-09
Enrollment: 227
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes of body fat percentages from baseline
timeFrame: week 8
measure: Changes of blood lipid profiles from baseline
timeFrame: week 8
measure: Changes of body fat percentages from baseline
timeFrame: week 16
measure: Changes of blood lipid profiles from baseline
timeFrame: week 16
measure: Changes of body fat percentages from baseline
timeFrame: week 20
measure: Changes of blood lipid profiles from baseline
timeFrame: week 20
Secondary outcomes:
measure: Changes of blood IL-6 levels
timeFrame: week 8
measure: Changes of blood IL-6 levels
timeFrame: week 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ICAN Nutrition Education and Research
Study officials:
References:
citation: 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.