Immune DeficiencyNCT02895204
Effect of Fermented Maillard Reacted Whey Protein on Immune Function
A study testing Fermented Maillard reacted whey protein (F-MRP) in people with Immune Deficiency, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- Fermented Maillard reacted whey protein (F-MRP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jun 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- The levels of white blood cells within range 3x10^3/μL~8x10^3/μL
- Males and females
- 20-70 years old
- Without no severe complications
Who cannot join
- Diabetes
- White blood cell under 3x10^3/μL or over 8x10^3/μL
- Pregnancy or breast-feeding
- Hypersensitivity or disease history for milk protein
- Liver disease, inflammation disease, or severe kidney failure disease
- Cancer, lung disease, leukemia, or autoimmune disease
Show all 10Show fewer
- Psychological or neurological disease
- Myocardiac infarction or cerebrovascular diseases within 6 months before screening
- Consumption of other test products or drugs within 1 month before screening
- Inflammation related disease within 1 month before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.
Read the detailed description
A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.
- Conditions
- Immune Deficiency
- Being tested
- Fermented Maillard reacted whey protein (F-MRP), Placebo
- Keywords
- Fermented Maillard reacted whey protein, Natural killer cell activity, Immune function, Pre-albumin, Interleukin-12
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Maillard reacted whey protein (F-MRP)Dietary supplement
6g of powder containing 4.2g fermented maillard reacted whey protein
PlaceboDietary supplement
6g of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Test group (F-MRP) | Experimental | Fermented Maillard reacted whey protein (F-MRP) supplementation Receives: Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP) |
| Placebo group | Placebo comparator | Placebo supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural killer cell activity
Measured: At baseline
Natural killer cell activity
Measured: At 8-week follow-up
Change from baseline natural killer cell activity at 8-week
Measured: At baseline and 8-week follow-up
Secondary outcomes (9)
White blood cell
Measured: At baseline
White blood cell
Measured: At 8-week follow-up
Change from baseline white blood cell at 8-week
Measured: At baseline and 8-week follow-up
Interleukin-12
Measured: At baseline
Interleukin-12
Measured: At 8-week follow-up
Change from baseline Interleukin-12 at 8-week
Measured: At baseline and 8-week follow-up
Interferon-gamma
Measured: At baseline
Interferon-gamma
Measured: At 8-week follow-up
Change from baseline Interferon-gamma at 8-week
Measured: At baseline and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DeficiencyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT02895204
- Sponsor's protocol ID
- SU_immune
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 13 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
- ClinicalTrials.gov ID
- NCT02895204
- Acronym / sponsor ID
- SU_immune
- Conditions
- Immune Deficiency
- Keywords
- Fermented Maillard reacted whey protein, Natural killer cell activity, Immune function, Pre-albumin, Interleukin-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Sep 2016 (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 supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.
Detailed description
A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (F-MRP) | Experimental | Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)Fermented Maillard reacted whey protein (F-MRP) supplementation |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to give informed consent
- The levels of white blood cells within range 3x10^3/μL~8x10^3/μL
- Males and females
- 20-70 years old
- Without no severe complications
Key exclusion criteria (10 listed)
- Diabetes
- White blood cell under 3x10^3/μL or over 8x10^3/μL
- Pregnancy or breast-feeding
- Hypersensitivity or disease history for milk protein
- Liver disease, inflammation disease, or severe kidney failure disease
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 |
|---|---|---|
| Fermented Maillard reacted whey protein (F-MRP)6g of powder containing 4.2g fermented maillard reacted whey protein | Dietary supplement | Test group (F-MRP) |
| Placebo6g of maltodextrin | Dietary supplement | Placebo group |
Primary outcome
Natural killer cell activity
Time frame: At baseline
Natural killer cell activity
Time frame: At 8-week follow-up
Change from baseline natural killer cell activity at 8-week
Time frame: At baseline and 8-week follow-up
9 secondary outcomes
White blood cell
Time frame: At baseline
White blood cell
Time frame: At 8-week follow-up
Change from baseline white blood cell at 8-week
Time frame: At baseline and 8-week follow-up
Interleukin-12
Time frame: At baseline
Interleukin-12
Time frame: At 8-week follow-up
Change from baseline Interleukin-12 at 8-week
Time frame: At baseline and 8-week follow-up
Interferon-gamma
Time frame: At baseline
Interferon-gamma
Time frame: At 8-week follow-up
Change from baseline Interferon-gamma at 8-week
Time frame: At baseline and 8-week follow-up
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 13 Feb 2017.
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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 study testing Fermented Maillard reacted whey protein (F-MRP) in people with Immune Deficiency, 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 10 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 13 Feb 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. 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.
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?
Natural killer cell activity (time frame: At baseline). The study lists 3 primary outcomes in all. 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 13 Feb 2017.