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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03923894

Recruitment Status Completed

First Posted April 23, 2019

Last update posted August 26, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Immunity
  • Intervention/Treatment: Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract
    Dietary Supplement: Placebo
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention
  • Official 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
  • Actual Study Start Date: February 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Blueberry Yeast Fermentation Freeze Dying Powder Extract
Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.
Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract
Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.
Placebo Comparator: Placebo
Placebo 2.07 g/day for 8 weeks.
Dietary Supplement: Placebo
Placebo 2.07 g/day for 8 weeks.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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).
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts
Locations

Korea, Republic of, Jeollabuk-do
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju

Sponsors and Collaborators

Chonbuk National University Hospital

More Information
  • Responsible Party: Chonbuk National University Hospital
  • ClinicalTrials.gov Identifier: NCT03923894 History of Changes
  • Other Study ID Numbers: MIFI-PI-BB
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: August 26, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No