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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01643096
Other study ID # 90-04-27-15366
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 15, 2012
Last updated July 16, 2012
Start date August 2012
Est. completion date August 2014

Study information

Verified date July 2012
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics CommitteeIran: Ministry of Health
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 2014
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Zataria multiflora Boiss
Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people
Sumac
Thermic effect of food of Sumac and comparison between hot and cold temperament people

Locations

Country Name City State
Iran, Islamic Republic of Tehran University of Medical Sciences Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thermic Effect of Food (TEF) kilocalorie(kcal) and by indirect calorimetery Change from baseline to 4 hours And repeated 1 week later No
Secondary activity of sympathetic - parasympathetic system(Epinephrine, Norepinephrine, Cortisol) ng/ml Change from baseline to 4 hours And repeated 1 week later No
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