NCT05256784

Brief Summary

Background/Objectives: The research discusses the importance of mountain foods/products and services in the context of healthier nutrition and behavior with the application to agribusiness. The purpose of the research is to highlight the necessity of human behavior in consuming mountain products as natural probiotics. Subjects/methods: As evidence, the research analyses mountain food and the associated entrepreneurship for Austria and other Central and Eastern European countries (foods/products and services), especially from the mountain area. The authors realized experimental research regarding representative mountain food from Central and Eastern European areas and used the Eurostat database. Data has been taken from Eurostat and processed in Excel and SPSS, using similar models of analysis from published research. Experimental analysis has been realized by the authors and collected from different recognized sources.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 11, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 2, 2022

Last Update Submit

March 31, 2022

Conditions

Outcome Measures

Primary Outcomes (22)

  • Laboratory blood tests 1

    Serum Calcium

    September 2021 - April 2022

  • Laboratory blood tests 2

    Serum Magnesium

    September 2021 - April 2022

  • Laboratory blood tests 3

    Serum Iron (Sideremia)

    September 2021 - April 2022

  • Laboratory blood tests 4

    Vitamin B12

    September 2021 - April 2022

  • Laboratory blood tests 5

    Serum Folate

    September 2021 - April 2022

  • Laboratory blood tests 6

    Vitamin 25-OH

    September 2021 - April 2022

  • Laboratory blood tests 7

    Leukocyte count

    September 2021 - April 2022

  • Laboratory blood tests 8

    Erythrocyte count

    September 2021 - April 2022

  • Laboratory blood tests 9

    Hemoglobin

    September 2021 - April 2022

  • Laboratory blood tests 10

    Hematocrit

    September 2021 - April 2022

  • Laboratory blood tests 11

    Mean erythrocyte volume

    September 2021 - April 2022

  • Laboratory blood tests 12

    Mean erythrocyte hemoglobin

    September 2021 - April 2022

  • Laboratory blood tests 13

    Mean Hb / erythrocyte concentration

    September 2021 - April 2022

  • Laboratory blood tests 14

    Erythrocyte distribution width

    September 2021 - April 2022

  • Laboratory blood tests 15

    Platelet count

    September 2021 - April 2022

  • Laboratory blood tests 16

    L platelet count platelet distribution

    September 2021 - April 2022

  • Laboratory blood tests 17

    Neutrophil

    September 2021 - April 2022

  • Laboratory blood tests 18

    Lymphocyte

    September 2021 - April 2022

  • Laboratory blood tests 19

    Monocyte

    September 2021 - April 2022

  • Laboratory blood tests 20

    Eosinophil

    September 2021 - April 2022

  • Laboratory blood tests 21

    Basophil

    September 2021 - April 2022

  • Laboratory blood tests 22

    Zinc in the blood

    September 2021 - April 2022

Study Arms (1)

Probiotic 1

Four members of an extended family: 1 white man of 71 years, 1 white woman of 75 years, 1 white man of 44 years, and 1 white woman of 44 years.

Combination Product: Natural probiotics

Interventions

Natural probioticsCOMBINATION_PRODUCT

Two of the group members use daily Allium Sativum - garlic, one use Natural honey, and 1 Yogurt. It is verifying the immunity of the organism after 40 days of using natural probitotics.

Probiotic 1

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Members of the same family, white men, and women from 44 to 75 years, have minor problems with immunity in the COVID-19 context.

You may qualify if:

  • members of the same extended family

You may not qualify if:

  • outside of the family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealandina Agency

London, WC2H 9JQ, United Kingdom

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Brindusa Covaci, Ph.D.

    Zealandina Agency & Centre for Mountain Economy

    STUDY DIRECTOR
  • Mihai Covaci, Ph.D.

    Zealandina Agency & Hyperion University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 25, 2022

Study Start

September 15, 2021

Primary Completion

January 26, 2022

Study Completion

March 31, 2022

Last Updated

April 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The family members, participants in the study, have consumed daily natural honey, yogurt, and garlic. After every 40 days, it has been verified, through laboratory analysis, the level of organism immunity. The analysis has been realized in different laboratories in Romania. It has been verified Biochemistry: Serum Calcium, Serum Magnesium, Serum Iron; Immunochemistry: Vitamin B12, Serum Folate, Vitamin 25-OH; Hematology: Leukocyte blood count with Hb, Ht, and indices (Leukocyte count, Erythrocyte count, Hemoglobin, Hematocrit, Mean erythrocyte volume, Mean erythrocyte hemoglobin, Mean Hb / erythrocyte concentration, Erythrocyte distribution width, Platelet count, Platelet distribution, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil); Zinc in the blood. Clinical studies and survival analysis realized for the research show that the immunity of the tested subjects has been improved during mountain products consumption (see detailed description).

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
September 2021 - April 2022
Access Criteria
Anyone
More information

Locations