Effects of; Food, AllergicNCT01643096
The Effect of Thyme and Sumac on the Thermic Effect of Food and Comparison Between Warm and Cold Temperament People
A study testing Zataria multiflora Boiss and Sumac in people with Effects of; Food, Allergic, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on the thermic effect of food, activity of sympathetic - parasympathetic system: comparison between warm and cold temperament people. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of; Food, Allergic
- What is being tested?
- Zataria multiflora Boiss and Sumac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 40 years
- Having to suffer any ill health and lack of attention to history and physical examination
- Willing to cooperate with the project
Who cannot join
- Catching any disease.
- Use of specific dietary patterns such as vegetarianism
- Having a BMI outside the normal range
- Use of any drugs or supplements in past month
- Allergic reaction to food allergy and non-prescription
- An unwillingness to cooperate in any of the stages of implementation
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences
Tehran
Dorosty Motlagh, PhD, (+98) 21 88951395, dorostim@sina.tums.ac.ir
Mohammadi Farsani, (+98) 21 88974462, mohammadigh53@gmail.com
About this study
The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on the thermic effect of food, activity of sympathetic - parasympathetic system: comparison between warm and cold temperament people.
Read the detailed description
Human body needs to energy in order to preserve life.There are three forms of energy consumption at body, consumption at baseline or resting, consumption at energy expenditure for Thermic effect of food and energy is spent in physical activity.Also from the perspective of traditional medicine, cold and warm natured people are determined based on certain mental and physical protests.
There are different temperament not only in Traditional Iranian Medicine, but in traditional Chinese medicine, Indian, Greek, Arabic, Romanian, and there are European.As various factors on the basal metabolism and thermic effect of food , also are several factors such as age, sex, physical condition of the environment that have an impact on individual temperament.
Since the protests seem warm and cool temperament and factors affecting on their basal metabolic rate and thermogenesis so that food may explain the relationship between warm and cold temperament to mind is the basal metabolism; It seems those are hot temperament, their basal metabolic rate is higher BMR than normal and those who are cold temperament, have a lower BMR.
On the other hand seems that thermic effect of food in people who have hot temperament is higher than thermic effect of food in people who have cold temperament.
So that we need to use of two nutrient foods, in this way we consided the multiple criteria and then were selected sumac and thyme.
On the other hand, in order to study possible mechanisms affecting basal metabolism, thermogenesis of food, according to previous studies and also matches that there are between sympathetic - parasympathetic and thyroid function, with symptoms of cold and warm temperament there, checking of activity of these organs seems necessary.
Because to maintain basal metabolic rate is essential for human life, so that each factor in order to better understand these is helpful to human life.And the need for such study makes clear;Through this step help toward improving public health
- Conditions
- Effects of; Food, Allergic
- Being tested
- Zataria multiflora Boiss, Sumac
- Keywords
- Zataria multiflora Boiss Sumac TEF temperament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zataria multiflora BoissOther
Also called Thyme
Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people
SumacOther
Also called sumach
Thermic effect of food of Sumac and comparison between hot and cold temperament people
| Study group | Role | What they receive |
|---|---|---|
| sumac | Other | Thermic effect of food of Sumac and comparison between hot and cold temperament people Receives: Other: Sumac |
| Zataria multiflora Boiss | Other | Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people Receives: Other: Zataria multiflora Boiss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermic Effect of Food (TEF)
kilocalorie(kcal) and by indirect calorimetery
Measured: Change from baseline to 4 hours And repeated 1 week later
Secondary outcomes (1)
activity of sympathetic - parasympathetic system(Epinephrine, Norepinephrine, Cortisol)
ng/ml
Measured: Change from baseline to 4 hours And repeated 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; Food, AllergicStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmadreza Dorosty Motlagh, PhD, Principal investigator, Tehran University of Medical Sciences, tehran, iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643096
- Sponsor's protocol ID
- 90-04-27-15366
- Status last verified
- Jul 2012
- First submitted
- 15 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thyme and Sumac on the Thermic Effect of Food and Comparison Between Warm and Cold Temperament People
- ClinicalTrials.gov ID
- NCT01643096
- Acronym / sponsor ID
- 90-04-27-15366
- Conditions
- Effects of; Food, Allergic
- Keywords
- Zataria multiflora Boiss Sumac TEF temperament
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- 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.
The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on the thermic effect of food, activity of sympathetic - parasympathetic system: comparison between warm and cold temperament people.
Detailed description
Human body needs to energy in order to preserve life.There are three forms of energy consumption at body, consumption at baseline or resting, consumption at energy expenditure for Thermic effect of food and energy is spent in physical activity.Also from the perspective of traditional medicine, cold and warm natured people are determined based on certain mental and physical protests.
There are different temperament not only in Traditional Iranian Medicine, but in traditional Chinese medicine, Indian, Greek, Arabic, Romanian, and there are European.As various factors on the basal metabolism and thermic effect of food , also are several factors such as age, sex, physical condition of the environment that have an impact on individual temperament.
Since the protests seem warm and cool temperament and factors affecting on their basal metabolic rate and thermogenesis so that food may explain the relationship between warm and cold temperament to mind is the basal metabolism; It seems those are hot temperament, their basal metabolic rate is higher BMR than normal and those who are cold temperament, have a lower BMR.
On the other hand seems that thermic effect of food in people who have hot temperament is higher than thermic effect of food in people who have cold temperament.
So that we need to use of two nutrient foods, in this way we consided the multiple criteria and then were selected sumac and thyme.
On the other hand, in order to study possible mechanisms affecting basal metabolism, thermogenesis of food, according to previous studies and also matches that there are between sympathetic - parasympathetic and thyroid function, with symptoms of cold and warm temperament there, checking of activity of these organs seems necessary.
Because to maintain basal metabolic rate is essential for human life, so that each factor in order to better understand these is helpful to human life.And the need for such study makes clear;Through this step help toward improving public health
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sumac | Other | Other: SumacThermic effect of food of Sumac and comparison between hot and cold temperament people |
| Zataria multiflora Boiss | Other | Other: Zataria multiflora BoissThermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 40 years
- Having to suffer any ill health and lack of attention to history and physical examination
- Willing to cooperate with the project
Key exclusion criteria (6 listed)
- Catching any disease.
- Use of specific dietary patterns such as vegetarianism
- Having a BMI outside the normal range
- Use of any drugs or supplements in past month
- Allergic reaction to food allergy and non-prescription
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 |
|---|---|---|
| Zataria multiflora BoissAlso: ThymeThermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people | Other | Zataria multiflora Boiss |
| SumacAlso: sumachThermic effect of food of Sumac and comparison between hot and cold temperament people | Other | sumac |
Primary outcome
Thermic Effect of Food (TEF)
Time frame: Change from baseline to 4 hours And repeated 1 week later
kilocalorie(kcal) and by indirect calorimetery
1 secondary outcome
activity of sympathetic - parasympathetic system(Epinephrine, Norepinephrine, Cortisol)
Time frame: Change from baseline to 4 hours And repeated 1 week later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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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.
Ahmadreza Dorosty Motlagh, PhD principal investigator
Tehran University of Medical Sciences, tehran, iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zataria multiflora Boiss and Sumac in people with Effects of; Food, Allergic, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Jul 2012. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermic Effect of Food (TEF) (time frame: Change from baseline to 4 hours And repeated 1 week later). 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 17 Jul 2012.