NCT02535663

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 healthy-volunteers

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_2 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

August 26, 2015

Last Update Submit

April 11, 2016

Conditions

Keywords

rhamnogalacturonanNatural killer cell activityinterleukin-12interferon-gammaimmune functioninflammatory

Outcome Measures

Primary Outcomes (1)

  • serum cytokine concentrations

    Primary outcome will be tested before and after intervention

    change from baseline in RG at 8 weeks

Study Arms (2)

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

Dietary Supplement: RG

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks

Dietary Supplement: Placebo

Interventions

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

test group
PlaceboDIETARY_SUPPLEMENT

Same product without RG

placebo

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The levels of white blood cells under 8x10\^3/μL
  • males and females
  • years old
  • nondiabetic and nonobese subjects
  • able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 120-749, South Korea

Location

Related Publications (1)

  • 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.

Study Officials

  • Jong-Ho Lee, PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 28, 2015

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations