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

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

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

Study Overview

• Status: Completed
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Natural Killer cell activity	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	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Cytokines	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.	8 week
Changes of Upper respiratory infection questionnaire score	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).	8 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MIFI-PI-BB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No