Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05256784 |
| Other study ID # |
Zealandina |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2021 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Zealandina Agency |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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).
