Healthy SubjectsNCT03431233
Effect of Premeal Protein-bar on Food Intake
A study testing Protein-enriched bar, commercial cereal bar, or water in people with Healthy Subjects, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Protein-enriched bar, commercial cereal bar, or water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 1 Jun 2019
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5~35 kg/m2
- Never diagnosed by diabetes
- Fasting plasma glucose <=100mg/dl and HbA1c <6.0%
Who cannot join
- Those who diagnosed by Type 1 or Type 2 diabetes
- Allergy to wheat, flour, nuts, milk
- Pregnancy/lactation
- AST or ALT >2.5 times of upper normal reference range
- eGFR <30 mL/min/1.73m2
- Hb <10g/dl
- History of GI surgery (except hemorrhoidectomy, appendectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects
The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.
Read the detailed description
Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.
- Conditions
- Healthy Subjects
- Being tested
- Protein-enriched bar, commercial cereal bar, or water
- Keywords
- protein-enriched bar, food intake, appetite, satiety related hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-enriched bar, commercial cereal bar, or waterDietary supplement
Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | protein enriched bar->commercial cereal bar->water Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
| Group 2 | Experimental | protein enriched bar->water->commercial cereal bar Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
| Group 3 | Experimental | commercial cereal bar->protein enriched bar->water Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
| Group 4 | Experimental | commercial cereal bar->water->protein enriched bar Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
| Group 5 | Experimental | water->protein enriched bar->commercial cereal bar Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
| Group 6 | Experimental | water->commercial cereal bar->protein enriched bar Receives: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
grams and caloric intake of standardized gimbap
Measured: 120min
Secondary outcomes (6)
Appetite (visual analogue scale : score 1 to 10)
(1: I am not hungry at all, 10: I have never been more hungry)
Measured: 120min
Satiety (visual analogue scale : score 1 to 10)
Measured: 120min
plasma glucose (mmol/L)
plasma level of glucose
Measured: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma active/total GLP-1 (pmol/L)
plasma level of active/total GLP-1
Measured: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma active ghrelin (ng/ml)
plasma level of active ghrelin
Measured: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma total peptide YY (pg/ml)
plasma level of peptide YY
Measured: -15min, 0(breakfast), 30, 60, 90, 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Aug 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Min Cho, Seoul National University Hospital
- Investigators
- Young Min Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431233
- Sponsor's protocol ID
- H-1705-091-855
- Status last verified
- Aug 2019
- First submitted
- 15 Jan 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03431233
- Acronym / sponsor ID
- H-1705-091-855
- Conditions
- Healthy Subjects
- Keywords
- protein-enriched bar, food intake, appetite, satiety related hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- 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 aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.
Detailed description
Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or waterprotein enriched bar->commercial cereal bar->water |
| Group 2 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or waterprotein enriched bar->water->commercial cereal bar |
| Group 3 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or watercommercial cereal bar->protein enriched bar->water |
| Group 4 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or watercommercial cereal bar->water->protein enriched bar |
| Group 5 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or waterwater->protein enriched bar->commercial cereal bar |
| Group 6 | Experimental | Dietary Supplement: Protein-enriched bar, commercial cereal bar, or waterwater->commercial cereal bar->protein enriched bar |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| Protein-enriched bar, commercial cereal bar, or waterProtein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast. | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Food intake
Time frame: 120min
grams and caloric intake of standardized gimbap
6 secondary outcomes
Appetite (visual analogue scale : score 1 to 10)
Time frame: 120min
Satiety (visual analogue scale : score 1 to 10)
Time frame: 120min
plasma glucose (mmol/L)
Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma active/total GLP-1 (pmol/L)
Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma active ghrelin (ng/ml)
Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min
plasma total peptide YY (pg/ml)
Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min
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 29 Aug 2019.
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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.
Young Min Cho, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-enriched bar, commercial cereal bar, or water in people with Healthy Subjects, run by Seoul National University Hospital 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 3 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 29 Aug 2019. 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?
Food intake (time frame: 120min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2019.