Consumption of Dairy Yogurt Enhanced Immune Function

Healthy Volunteers Clinical Trial

Official title:

Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535663
• Other study ID #: YF_immune
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 26, 2015
• Last updated: April 11, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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
Same product without RG

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum cytokine concentrations	Primary outcome will be tested before and after intervention	change from baseline in RG at 8 weeks	Yes