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

Study Overview
=================
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.

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

Conditions
-----------------
Adult Young and Healthy

Intervention / Treatment
-----------------
* Other: almond
* Other: high-carbohydrate control food


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: almond<br>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<br> <br> |
| Other: high-carbohydrate control food item<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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