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Trial record 8 of 228 for:    yeast

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923894
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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 Intervention/treatment Phase
Immunity Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 14, 2019
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine


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.




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).




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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923894


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Sponsors and Collaborators
Chonbuk National University Hospital

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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No