Adult Young and HealthyNCT03014531
Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults
A study testing almond in people with Adult Young and Healthy, run by ICAN Nutrition Education and Research at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Young and Healthy
- What is being tested?
- almond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers
- age 20-39 yr
- Male and Female non-smokers
- BMI 17-30 kg/m2
- under Korean habitual diet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Adult Young and Healthy
- Being tested
- almond, high-carbohydrate control food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
almondOther
high-carbohydrate control foodOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: high-carbohydrate control food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of body fat percentages from baseline
Measured: week 8
Changes of blood lipid profiles from baseline
Measured: week 8
Changes of body fat percentages from baseline
Measured: week 16
Changes of blood lipid profiles from baseline
Measured: week 16
Changes of body fat percentages from baseline
Measured: week 20
Changes of blood lipid profiles from baseline
Measured: week 20
Secondary outcomes (2)
Changes of blood IL-6 levels
Measured: week 8
Changes of blood IL-6 levels
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Young and HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICAN Nutrition Education and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014531
- Sponsor's protocol ID
- 14-KIMH-01-ICAN
- Status last verified
- Aug 2017
- First submitted
- 25 Dec 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03014531
- Acronym / sponsor ID
- 14-KIMH-01-ICAN
- Conditions
- Adult Young and Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- ICAN Nutrition Education and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Almond Board of California
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| almond | Experimental | Other: almondIn 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. |
| high-carbohydrate control food item | Other | Other: high-carbohydrate control foodIn this group, participants were provided with high-carbohydrate control food item that had a similar number of calories as 56 g of almonds. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-smokers
- age 20-39 yr
- Male and Female non-smokers
- BMI 17-30 kg/m2
- under Korean habitual diet
Key exclusion criteria (7 listed)
- any diseases
- any weight change 6 mo before the study
- >2 times/wk nut consumption
- frequent alcohol consumption
- any use of nutrient supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| almond | Other | almond |
| high-carbohydrate control food | Other | high-carbohydrate control food item |
Primary outcome
Changes of body fat percentages from baseline
Time frame: week 8
Changes of blood lipid profiles from baseline
Time frame: week 8
Changes of body fat percentages from baseline
Time frame: week 16
Changes of blood lipid profiles from baseline
Time frame: week 16
Changes of body fat percentages from baseline
Time frame: week 20
Changes of blood lipid profiles from baseline
Time frame: week 20
2 secondary outcomes
Changes of blood IL-6 levels
Time frame: week 8
Changes of blood IL-6 levels
Time frame: week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Derived from this study: PubMed 29209458Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing almond in people with Adult Young and Healthy, run by ICAN Nutrition Education and Research at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of body fat percentages from baseline (time frame: week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.