Healthy VolunteersPhase 2/3NCT02535663
Consumption of Dairy Yogurt Enhanced Immune Function
A Phase 2/3 study testing RG in people with Healthy Volunteers, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2015
- Phase
- Phase 2/3
- 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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The levels of white blood cells under 8x10^3/μL
- males and females
- 30-69 years old
- nondiabetic and nonobese subjects
- able to give informed consent
Who cannot join
- consumption of any probiotic products within 1 month before screening
- unstable body weight (body-weight change > 2 kg within 3 months before screening)
- diabetes
- history/presence of significant metabolic disease
- pregnancy or breast-feeding
- acute or chronic infection
- liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment
- subjects taking any drugs or supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response
To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels.
Read the detailed description
A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG, 20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC) from each participant to Target cell (T) (K562 cells) as 10:1, 5:1, 2.5:1 or 1.25:1.
- Conditions
- Healthy Volunteers
- Being tested
- RG, Placebo
- Keywords
- rhamnogalacturonan, Natural killer cell activity, interleukin-12, interferon-gamma, immune function, inflammatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGDietary supplement
The 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture
PlaceboDietary supplement
Same product without RG
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Dietary Supplement: RG consumed one pack (150ml) of dairy yogurt containing RG (100mg Korean citrus Hallabong peel polysaccharide) per day for 8 weeks Receives: Dietary Supplement: RG |
| placebo | Placebo comparator | Dietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cytokine concentrations
Primary outcome will be tested before and after intervention
Measured: change from baseline in RG at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Ho Lee, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535663
- Sponsor's protocol ID
- YF_immune
- Status last verified
- Apr 2016
- First submitted
- 26 Aug 2015
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee MH, Kim M, Kim M, Kwak JH, Chang DH, Yu WK, Lee SH, Lee JH. Consumption of dairy yogurt with the polysaccharide rhamnogalacturonan from the peel of the Korean citrus hallabong enhances immune function and attenuates the inflammatory response. Food Funct. 2016 Jun 15;7(6):2833-9. doi: 10.1039/c5fo01103e.
PubMed 27225729
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response
- ClinicalTrials.gov ID
- NCT02535663
- Acronym / sponsor ID
- YF_immune
- Conditions
- Healthy Volunteers
- Keywords
- rhamnogalacturonan, Natural killer cell activity, interleukin-12, interferon-gamma, immune function, inflammatory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Aug 2015 (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.
To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels.
Detailed description
A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG, 20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC) from each participant to Target cell (T) (K562 cells) as 10:1, 5:1, 2.5:1 or 1.25:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Dietary Supplement: RGDietary Supplement: RG consumed one pack (150ml) of dairy yogurt containing RG (100mg Korean citrus Hallabong peel polysaccharide) per day for 8 weeks |
| placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The levels of white blood cells under 8x10^3/μL
- males and females
- 30-69 years old
- nondiabetic and nonobese subjects
- able to give informed consent
Key exclusion criteria (8 listed)
- consumption of any probiotic products within 1 month before screening
- unstable body weight (body-weight change > 2 kg within 3 months before screening)
- diabetes
- history/presence of significant metabolic disease
- pregnancy or breast-feeding
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 |
|---|---|---|
| RGThe 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture | Dietary supplement | test group |
| PlaceboSame product without RG | Dietary supplement | placebo |
Primary outcome
serum cytokine concentrations
Time frame: change from baseline in RG at 8 weeks
Primary outcome will be tested before and after intervention
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 12 Apr 2016.
- Derived from this study: PubMed 27225729Lee MH, Kim M, Kim M, Kwak JH, Chang DH, Yu WK, Lee SH, Lee JH. Consumption of dairy yogurt with the polysaccharide rhamnogalacturonan from the peel of the Korean citrus hallabong enhances immune function and attenuates the inflammatory response. Food Funct. 2016 Jun 15;7(6):2833-9. doi: 10.1039/c5fo01103e.
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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.
Jong-Ho Lee, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RG in people with Healthy Volunteers, run by Yonsei University 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 8 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 12 Apr 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum cytokine concentrations (time frame: change from baseline in RG at 8 weeks). 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 NCT02535663, 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 12 Apr 2016.