Skip to main content
OpenTrials
Completed

NCT Number: NCT03923894

the Efficacy and Safety of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity

This study was conducted to investigated the effects of daily supplementation of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immunity

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

This study was a 8-week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into Blueberry Yeast Fermentation Freeze Dying Powder extract 2.07 g or placebo group. The investigated measured Natural Killer cell activity, Cytokines, Upper respiratory infection questionnaire score, etc.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult men and women over 50 years
  • After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion criteria

  • If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
  • Those who received influenza vaccination within 3 months before the screening
  • Those who have a body mass index(BMI) of less than 18.5 kg / m2 or greater than 35 kg / m2 at the screening
  • Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
  • Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
  • Those who have received antipsychotic medication within 3 months before screening
  • Those who alcoholic or drug abuse suspected
  • Those who participated in other clinical trials within 3 months before screening
  • Laboratory test by show the following results
  • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
  • Serum Creatinine > 2.0 mg/dL
  • Pregnancy or breast feeding
  • Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
  • Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Treatment and study plan

Blueberry Yeast Fermentation Freeze Dying Powder Extract

Dietary Supplement

Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.

Placebo

Dietary Supplement

Placebo 2.07 g/day for 8 weeks.

Primary outcomes

  1. Changes of Natural Killer cell activity

    Time frame: 8 week

    Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 50:1, 25:1, 12.5:1.

    (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100

Secondary outcomes

  1. Changes of Cytokines

    Time frame: 8 week

    For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes.

    Inspection item were IL-2, IL-6, IL-12, IFN-γ, TNF-α.

  2. Changes of Upper respiratory infection questionnaire score

    Time frame: 8 week

    The upper respiratory infection questionnaire will investigate the occurrence of symptoms of upper respiratory infections (or symptoms), the score by symptom, the duration (days), and survey on the day of visit (1st, 2nd and 3rd visits).

    The questionnaire items were classified into three groups according to whether or not the symptoms of upper respiratory infections (or symptoms) occurrence (yes or no), the types of symptoms (sore throat, rhinorrhea, nasal obstruction, sneezing, hoarseness, myalgia, earache, fever, headache, cough, sputum, dyspnea, diarrhea, nausea, vomiting)and symptoms level (0 if no symptoms, 1 if slightly, 2 if normal, 3 severe).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Aug 26, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.