Consumption of Dairy Yogurt Enhanced Immune Function

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: RG; Dietary Supplement: Placebo

• Registration Number: NCT02535663
• Lead Sponsor: Yonsei University

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.

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
test group	RG	Dietary Supplement: RG consumed one pack (150ml) of dairy yogurt containing RG (100mg Korean citrus Hallabong peel polysaccharide) per day for 8 weeks
placebo	Placebo	Dietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
serum cytokine concentrations	change from baseline in RG at 8 weeks	Primary outcome will be tested before and after intervention

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of