Immune DeficiencyNCT05256784
Mountain Food and Natural Probiotic in Nutrition
An observational study of Immune Deficiency, run by Zealandina Agency at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- Natural probiotics
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- members of the same extended family
Who cannot join
- outside of the family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mountain Food, as a Natural Probiotic. Evidence From Central and Eastern European Nutrition and Behavior
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.
Read the detailed description
The study is focused on performing qualitative research for natural yogurt (animal resource), Allium sativum - garlic (plant resource), experimental analysis for natural honey (apicultural resource), namely honey-dew (manna) which is a mountain product from Maramureș, a region of Romania, and polyflora honey (Tilia - linden with mountain flowers) which is a hilly product from Moldova, a region of Romania, and clinical study on all the mountain products reminded before.
After this study, it will be a comparative study of consumer behavior of mountain products from Central and Eastern European countries and Central and Southern states from the USA.
This study is referring strictly to Central and Eastern European countries, especially Romania (but a country like Romania is representative of the other studied countries). The members of the family which will participate in the study will consume the probiotics reminded before. The family members, participants in the study, are consuming daily natural honey (one member of the family), yogurt (one member of the family), and garlic (two of them). After every 40 days, it will be verified, through laboratory analysis, the level of organism immunity. The analysis will be realized in Synevo Romania. It will be verified Biochemistry: Serum Calcium, Serum Magnesium, Serum Iron (Sideremia); 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, L platelet count platelet distribution, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil); Zinc in the blood.
It will be verified if properly used mountain animal and vegetal resources can become powerful fighters as natural probiotics against various diseases, or to prevent different immunity problems.
Fermented natural dairy products are an extremely important component in the diet of the CEE population, especially for the rural population. Dairy products are often used as natural probiotics, especially within CEE countries. And, the most used mountain product is yogurt (or derivate products similar wit it, such as kefir, ayran, and so on). Within CEE countries, the most important species isolated from lactic bacteria fermented or raw products of dairy origin, are Lactococcus lactis, Leuconostoc sp., and Enterococcus sp. Probiotic dairy products have been analyzed and shown that in addition to nutritional benefits, they positively influence the physiology of the human body. The best-known dairy products are ice cream, cheese, yogurt, milk enriched with strains of Acidophilus and Bifidus, ayran, kefir, and kumis. Dairy drinks (fermented or unfermented) are considered foods that provide probiotics. In the fermentation process, lactic, acetic, and citric acid are naturally obtained, acids that are frequently used in the food industry to improve the organoleptic qualities of several products intended for consumption. The father of the paradigm according to which yogurt is one of the most powerful probiotics, especially for the digestive system, was Elie Metchnikoff, Nobel Laureate for Medicine. He postulated in the famous public presentation "Old Age", held at the Society of French Agriculturalists in Paris on June 8, 1904, that the dependence between lactic acid bacteria and food makes it possible to apply methods to modify the intestinal flora by replacing bad bacteria with beneficial ones. He suggested that yogurt bacteria prevent and annihilate intestinal bacterial infections and hypothesize that regular yogurt consumption prolongs life. Lactic acid bacteria produce microbial metabolism, and the effect is a decrease in intestinal pH, which stops the proliferation of various proteolytic bacterial species. In this way, Metchnikoff kicks off the popularization of yogurt in Europe as a functional food with health benefits.
Regarding plant resources, CEE countries are specialized in using different plants as natural probiotics. But, the most used plant resource is Allium sativum (garlic). Garlic consumption, as a natural probiotic, is just as old in the CEE as in many other countries around the world. Garlic is listed in the Dietary Guide for Americans 2015-2020. Garlic intake variants (capsules, aqueous extract, old alcoholic extract, etc.) are not very popular in the CEE, the preference being clear for the raw version.
The experimental analysis of the study, realized by the authors in accordance with Romanian Research-Development National Institute for Apiculture - Bulletin analysis 39/29.01.2021, show that both types of natural honey have the same diastase index, meaning 29.4±0.18 unities on Goethe; mountain honey has sucrose (β-D-Fructofuranosyl α-D-glucopyranoside) of 2.41±0.43 %, g/g, while hilly products have 2.19±0.39 %, g/g; reducing sugar is in percent of 76.18±3.40 %, g/g and to the other of 75.67±3.37 %, g/g; 5-Hydroxymethylfurfural has a value of 0.10±0.01 mg/100g of honey for the mountain product and 0.19±0.03; mg/100g of honey for the hilly product; mountain honey has a superior PH value of 3.00±0.46 milliliters Sodium hydroxide solutions 1N/100 g of honey and the other of 2.80±0.43 milliliters Sodium hydroxide solutions 1N/100 g of honey; moisture contents has a percentage of 17.20±0.24 %, g/g for the mountain product and of 16.80±0.24 %, g/g for the other type of honey; pollen analysis present percentages of 98% of manna and 2% of mountain polyflora for the mountain product and of 95% of linden and 5% of manna for the other type of mountain; electrical conductivity present a value of 0.55 mS/cm, while ashes are in the value of 0,21±0,02 %, g/g (mountain product) and 0,44±0,03 %, g/g (hilly product); fructose (3S,4R,5R)-1,3,4,5,6-Pentahydroxyhexan-2-one) present a percentage of 41.06 %, g/g (mountain honey) and 40.10 %, g/g (hilly honey) and glucose (2R,3S,4R,5R)-2,3,4,5,6-Pentahydroxyhexanal) a percentage of 35.12 %, g/g (mountain product) and 35.57 %, g/g (hilly product). The physicochemical analysis shows that mountain honey has more qualitative values than hilly honey. Honey-dew (manna) contains minerals (calcium, magnesium, iron, potassium, phosphorus, selenium), antioxidants, organic acids, bioflavonoids, vitamins (especially C and group B), inhibin (strong bactericide), and enzymes. Minerals, proteins, and some acids are found in amounts five to ten times higher in mountain honey than in hilly honey.
It has been verified if properly used mountain animals and vegetal resources (as natural probiotics) can prevent or fight for human immunity.
Regarding Yogurt consumption, the influence on human immunity presents considerable values for magnesium, vitamin D, leukocyte, mean corpuscular hemoglobin, average hemoglobin/erythrocyte concentration, lymphocyte, monocyte, eosinophilic, basophil, and zinc. Different studies confirm the positive influence of yogurt consumption on immunity, as Yang et al. (2022), Ravindran et al. (2022), Kim et al. (2020), Gasparri et al. (2019), Meydani (2000), Leonard (2018), Jafari et al. (2016), Ajibola et al. (2012), Asemi et al. (2012). Allium sativum (garlic) influence positively the immunity of the organism, modifying the values of vitamin D, erythrocyte distribution width, platelets, and platelet distribution width, neutrophil, monocyte, and zinc. The influence of garlic on immunity is confirmed by numerous studies, such as Bandyopadhyay et al. (2021), Singh et al. (2021), Eor et al. (2020), Lee et al. (2020), Champagne et al. (2018), Divya et. al (2017), Percival (2016), Gholipour Kanani et al. (2014), Ried et al. (2014), Hamlaoui-Gasmi et al. (2012), Samson et al. (2012), Mukherjee et al. (2006), Hodge et al. (2002), Oluwole (2001), etc. Natural honey, especially manna honey, is considered to be one of the most powerful fighters of human immunity. According to our clinical analysis mountain honey has a positive effect on the adjustment of calcium, magnesium, vitamin B12, folates, vitamin D, mean corpuscular hemoglobin (MCH), Average Hgb / erythrocyte concentration, erythrocyte distribution width, platelets, lymphocyte, monocyte and eosinophilic. Complex research, clinical and experimental, sustain the importance of natural honey in immunodeficiency, studies as Attia et al. (2022), Bakour et al. (2022), Martínez-Puc et al. (2022), Ismail et al. (2022), Abdulrhman (2018), Sell et al. (2012), Ahmed et al. (2011), Al-Waili (2003), Kitzes (1943).
- Conditions
- Immune Deficiency
- Being tested
- Natural probiotics
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Natural probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory blood tests 1
Serum Calcium
Measured: September 2021 - April 2022
Laboratory blood tests 2
Serum Magnesium
Measured: September 2021 - April 2022
Laboratory blood tests 3
Serum Iron (Sideremia)
Measured: September 2021 - April 2022
Laboratory blood tests 4
Vitamin B12
Measured: September 2021 - April 2022
Laboratory blood tests 5
Serum Folate
Measured: September 2021 - April 2022
Laboratory blood tests 6
Vitamin 25-OH
Measured: September 2021 - April 2022
Laboratory blood tests 7
Leukocyte count
Measured: September 2021 - April 2022
Laboratory blood tests 8
Erythrocyte count
Measured: September 2021 - April 2022
Laboratory blood tests 9
Hemoglobin
Measured: September 2021 - April 2022
Laboratory blood tests 10
Hematocrit
Measured: September 2021 - April 2022
Laboratory blood tests 11
Mean erythrocyte volume
Measured: September 2021 - April 2022
Laboratory blood tests 12
Mean erythrocyte hemoglobin
Measured: September 2021 - April 2022
Laboratory blood tests 13
Mean Hb / erythrocyte concentration
Measured: September 2021 - April 2022
Laboratory blood tests 14
Erythrocyte distribution width
Measured: September 2021 - April 2022
Laboratory blood tests 15
Platelet count
Measured: September 2021 - April 2022
Laboratory blood tests 16
L platelet count platelet distribution
Measured: September 2021 - April 2022
Laboratory blood tests 17
Neutrophil
Measured: September 2021 - April 2022
Laboratory blood tests 18
Lymphocyte
Measured: September 2021 - April 2022
Laboratory blood tests 19
Monocyte
Measured: September 2021 - April 2022
Laboratory blood tests 20
Eosinophil
Measured: September 2021 - April 2022
Laboratory blood tests 21
Basophil
Measured: September 2021 - April 2022
Laboratory blood tests 22
Zinc in the blood
Measured: September 2021 - April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Sep 2021
- Primary completion26 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealandina Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brindusa Covaci, Ph.D., Study director, Zealandina Agency & Centre for Mountain EconomyMihai Covaci, Ph.D., Principal investigator, Zealandina Agency & Hyperion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256784
- Sponsor's protocol ID
- Zealandina
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mountain Food, as a Natural Probiotic. Evidence From Central and Eastern European Nutrition and Behavior
- ClinicalTrials.gov ID
- NCT05256784
- Acronym / sponsor ID
- Zealandina
- Conditions
- Immune Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zealandina AgencyUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is focused on performing qualitative research for natural yogurt (animal resource), Allium sativum - garlic (plant resource), experimental analysis for natural honey (apicultural resource), namely honey-dew (manna) which is a mountain product from Maramureș, a region of Romania, and polyflora honey (Tilia - linden with mountain flowers) which is a hilly product from Moldova, a region of Romania, and clinical study on all the mountain products reminded before.
After this study, it will be a comparative study of consumer behavior of mountain products from Central and Eastern European countries and Central and Southern states from the USA.
This study is referring strictly to Central and Eastern European countries, especially Romania (but a country like Romania is representative of the other studied countries). The members of the family which will participate in the study will consume the probiotics reminded before. The family members, participants in the study, are consuming daily natural honey (one member of the family), yogurt (one member of the family), and garlic (two of them). After every 40 days, it will be verified, through laboratory analysis, the level of organism immunity. The analysis will be realized in Synevo Romania. It will be verified Biochemistry: Serum Calcium, Serum Magnesium, Serum Iron (Sideremia); 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, L platelet count platelet distribution, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil); Zinc in the blood.
It will be verified if properly used mountain animal and vegetal resources can become powerful fighters as natural probiotics against various diseases, or to prevent different immunity problems.
Fermented natural dairy products are an extremely important component in the diet of the CEE population, especially for the rural population. Dairy products are often used as natural probiotics, especially within CEE countries. And, the most used mountain product is yogurt (or derivate products similar wit it, such as kefir, ayran, and so on). Within CEE countries, the most important species isolated from lactic bacteria fermented or raw products of dairy origin, are Lactococcus lactis, Leuconostoc sp., and Enterococcus sp. Probiotic dairy products have been analyzed and shown that in addition to nutritional benefits, they positively influence the physiology of the human body. The best-known dairy products are ice cream, cheese, yogurt, milk enriched with strains of Acidophilus and Bifidus, ayran, kefir, and kumis. Dairy drinks (fermented or unfermented) are considered foods that provide probiotics. In the fermentation process, lactic, acetic, and citric acid are naturally obtained, acids that are frequently used in the food industry to improve the organoleptic qualities of several products intended for consumption. The father of the paradigm according to which yogurt is one of the most powerful probiotics, especially for the digestive system, was Elie Metchnikoff, Nobel Laureate for Medicine. He postulated in the famous public presentation "Old Age", held at the Society of French Agriculturalists in Paris on June 8, 1904, that the dependence between lactic acid bacteria and food makes it possible to apply methods to modify the intestinal flora by replacing bad bacteria with beneficial ones. He suggested that yogurt bacteria prevent and annihilate intestinal bacterial infections and hypothesize that regular yogurt consumption prolongs life. Lactic acid bacteria produce microbial metabolism, and the effect is a decrease in intestinal pH, which stops the proliferation of various proteolytic bacterial species. In this way, Metchnikoff kicks off the popularization of yogurt in Europe as a functional food with health benefits.
Regarding plant resources, CEE countries are specialized in using different plants as natural probiotics. But, the most used plant resource is Allium sativum (garlic). Garlic consumption, as a natural probiotic, is just as old in the CEE as in many other countries around the world. Garlic is listed in the Dietary Guide for Americans 2015-2020. Garlic intake variants (capsules, aqueous extract, old alcoholic extract, etc.) are not very popular in the CEE, the preference being clear for the raw version.
The experimental analysis of the study, realized by the authors in accordance with Romanian Research-Development National Institute for Apiculture - Bulletin analysis 39/29.01.2021, show that both types of natural honey have the same diastase index, meaning 29.4±0.18 unities on Goethe; mountain honey has sucrose (β-D-Fructofuranosyl α-D-glucopyranoside) of 2.41±0.43 %, g/g, while hilly products have 2.19±0.39 %, g/g; reducing sugar is in percent of 76.18±3.40 %, g/g and to the other of 75.67±3.37 %, g/g; 5-Hydroxymethylfurfural has a value of 0.10±0.01 mg/100g of honey for the mountain product and 0.19±0.03; mg/100g of honey for the hilly product; mountain honey has a superior PH value of 3.00±0.46 milliliters Sodium hydroxide solutions 1N/100 g of honey and the other of 2.80±0.43 milliliters Sodium hydroxide solutions 1N/100 g of honey; moisture contents has a percentage of 17.20±0.24 %, g/g for the mountain product and of 16.80±0.24 %, g/g for the other type of honey; pollen analysis present percentages of 98% of manna and 2% of mountain polyflora for the mountain product and of 95% of linden and 5% of manna for the other type of mountain; electrical conductivity present a value of 0.55 mS/cm, while ashes are in the value of 0,21±0,02 %, g/g (mountain product) and 0,44±0,03 %, g/g (hilly product); fructose (3S,4R,5R)-1,3,4,5,6-Pentahydroxyhexan-2-one) present a percentage of 41.06 %, g/g (mountain honey) and 40.10 %, g/g (hilly honey) and glucose (2R,3S,4R,5R)-2,3,4,5,6-Pentahydroxyhexanal) a percentage of 35.12 %, g/g (mountain product) and 35.57 %, g/g (hilly product). The physicochemical analysis shows that mountain honey has more qualitative values than hilly honey. Honey-dew (manna) contains minerals (calcium, magnesium, iron, potassium, phosphorus, selenium), antioxidants, organic acids, bioflavonoids, vitamins (especially C and group B), inhibin (strong bactericide), and enzymes. Minerals, proteins, and some acids are found in amounts five to ten times higher in mountain honey than in hilly honey.
It has been verified if properly used mountain animals and vegetal resources (as natural probiotics) can prevent or fight for human immunity.
Regarding Yogurt consumption, the influence on human immunity presents considerable values for magnesium, vitamin D, leukocyte, mean corpuscular hemoglobin, average hemoglobin/erythrocyte concentration, lymphocyte, monocyte, eosinophilic, basophil, and zinc. Different studies confirm the positive influence of yogurt consumption on immunity, as Yang et al. (2022), Ravindran et al. (2022), Kim et al. (2020), Gasparri et al. (2019), Meydani (2000), Leonard (2018), Jafari et al. (2016), Ajibola et al. (2012), Asemi et al. (2012). Allium sativum (garlic) influence positively the immunity of the organism, modifying the values of vitamin D, erythrocyte distribution width, platelets, and platelet distribution width, neutrophil, monocyte, and zinc. The influence of garlic on immunity is confirmed by numerous studies, such as Bandyopadhyay et al. (2021), Singh et al. (2021), Eor et al. (2020), Lee et al. (2020), Champagne et al. (2018), Divya et. al (2017), Percival (2016), Gholipour Kanani et al. (2014), Ried et al. (2014), Hamlaoui-Gasmi et al. (2012), Samson et al. (2012), Mukherjee et al. (2006), Hodge et al. (2002), Oluwole (2001), etc. Natural honey, especially manna honey, is considered to be one of the most powerful fighters of human immunity. According to our clinical analysis mountain honey has a positive effect on the adjustment of calcium, magnesium, vitamin B12, folates, vitamin D, mean corpuscular hemoglobin (MCH), Average Hgb / erythrocyte concentration, erythrocyte distribution width, platelets, lymphocyte, monocyte and eosinophilic. Complex research, clinical and experimental, sustain the importance of natural honey in immunodeficiency, studies as Attia et al. (2022), Bakour et al. (2022), Martínez-Puc et al. (2022), Ismail et al. (2022), Abdulrhman (2018), Sell et al. (2012), Ahmed et al. (2011), Al-Waili (2003), Kitzes (1943).
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 | – | Combination Product: Natural probioticsFour 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- members of the same extended family
Key exclusion criteria (1 listed)
- outside of the family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural probioticsTwo 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. | Combination product | Probiotic 1 |
Primary outcome
Laboratory blood tests 1
Time frame: September 2021 - April 2022
Serum Calcium
Laboratory blood tests 2
Time frame: September 2021 - April 2022
Serum Magnesium
Laboratory blood tests 3
Time frame: September 2021 - April 2022
Serum Iron (Sideremia)
Laboratory blood tests 4
Time frame: September 2021 - April 2022
Vitamin B12
Laboratory blood tests 5
Time frame: September 2021 - April 2022
Serum Folate
Laboratory blood tests 6
Time frame: September 2021 - April 2022
Vitamin 25-OH
Laboratory blood tests 7
Time frame: September 2021 - April 2022
Leukocyte count
Laboratory blood tests 8
Time frame: September 2021 - April 2022
Erythrocyte count
Laboratory blood tests 9
Time frame: September 2021 - April 2022
Hemoglobin
Laboratory blood tests 10
Time frame: September 2021 - April 2022
Hematocrit
Laboratory blood tests 11
Time frame: September 2021 - April 2022
Mean erythrocyte volume
Laboratory blood tests 12
Time frame: September 2021 - April 2022
Mean erythrocyte hemoglobin
Laboratory blood tests 13
Time frame: September 2021 - April 2022
Mean Hb / erythrocyte concentration
Laboratory blood tests 14
Time frame: September 2021 - April 2022
Erythrocyte distribution width
Laboratory blood tests 15
Time frame: September 2021 - April 2022
Platelet count
Laboratory blood tests 16
Time frame: September 2021 - April 2022
L platelet count platelet distribution
Laboratory blood tests 17
Time frame: September 2021 - April 2022
Neutrophil
Laboratory blood tests 18
Time frame: September 2021 - April 2022
Lymphocyte
Laboratory blood tests 19
Time frame: September 2021 - April 2022
Monocyte
Laboratory blood tests 20
Time frame: September 2021 - April 2022
Eosinophil
Laboratory blood tests 21
Time frame: September 2021 - April 2022
Basophil
Laboratory blood tests 22
Time frame: September 2021 - April 2022
Zinc in the blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brindusa Covaci, Ph.D. study director
Zealandina Agency & Centre for Mountain Economy
Mihai Covaci, Ph.D. principal investigator
Zealandina Agency & Hyperion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Deficiency, run by Zealandina Agency at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory blood tests 1 (time frame: September 2021 - April 2022). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.