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Completed

NCT Number: NCT02535663

Consumption of Dairy Yogurt Enhanced Immune Function

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.

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Key information

Conditions

Healthy Volunteers

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yonsei University

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RG

Dietary Supplement

The 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture

Placebo

Dietary Supplement

Same product without RG

Primary outcomes

  1. serum cytokine concentrations

    Time frame: change from baseline in RG at 8 weeks

    Primary outcome will be tested before and after intervention

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2015
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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