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

Chonbuk National University

Status: Completed

Conditions: Immunity

Treatments: Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03923894

MIFI-PI-BB

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Blueberry Yeast Fermentation Freeze Dying Powder Extract

Experimental group

Description:

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

Treatment:

Dietary Supplement: Blueberry Yeast Fermentation Freeze Dying Powder Extract

Placebo

Placebo Comparator group

Description:

Placebo 2.07 g/day for 8 weeks.

Treatment:

Dietary Supplement: Placebo