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

NCT03923894 | Completed DMC

• 1 other identifier: MIFI-PI-BB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes of Cytokines

  8 week

• Changes of Upper respiratory infection questionnaire score

  8 week

Study Arms (2)

Blueberry Yeast Fermentation Freeze Dying Powder Extract

EXPERIMENTAL

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

Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract

Placebo

PLACEBO COMPARATOR

Placebo 2.07 g/day for 8 weeks.

Dietary Supplement: Placebo

Interventions

Blueberry Yeast Fermentation Freeze Dying Powder Extract DIETARY_SUPPLEMENT

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

Blueberry Yeast Fermentation Freeze Dying Powder Extract

Placebo DIETARY_SUPPLEMENT

Placebo 2.07 g/day for 8 weeks.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: February 14, 2019
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

KR (1)