Trial record 2 of 197314 for:    ALL

Consumption of Dairy Yogurt Enhanced Immune Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02535663
First received: August 26, 2015
Last updated: NA
Last verified: August 2015
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Dietary Supplement: RG
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • serum cytokine concentrations [ Time Frame: change from baseline in RG at 8 weeks ] [ Designated as safety issue: Yes ]
    Primary outcome will be tested before and after intervention


Enrollment: 120
Study Start Date: June 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test group
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
The 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture
Placebo Comparator: placebo
Dietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males and females
  • 30-69 years old
  • nondiabetic and nonobese subjects
  • able to give informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02535663

Locations
Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jong-Ho Lee, PhD Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02535663     History of Changes
Other Study ID Numbers: YF_immune
Study First Received: August 26, 2015
Last Updated: August 26, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
rhamnogalacturonan
Natural killer cell activity
interleukin-12
interferon-gamma
immune function
inflammatory

ClinicalTrials.gov processed this record on August 27, 2015