The Effect of Thyme and Sumac on the Thermic Effect of Food and Comparison Between Warm and Cold Temperament People

July 16, 2012 updated by: Tehran University of Medical Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: sumac
Thermic effect of food of Sumac and comparison between hot and cold temperament people
Other: Sumac
Thermic effect of food of Sumac and comparison between hot and cold temperament people
Other Names:
  • sumach
OTHER: Zataria multiflora Boiss
Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people
Other: Zataria multiflora Boiss
Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people
Other Names:
  • Thyme

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thermic Effect of Food (TEF)
Time Frame: Change from baseline to 4 hours And repeated 1 week later
kilocalorie(kcal) and by indirect calorimetery
Change from baseline to 4 hours And repeated 1 week later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
activity of sympathetic - parasympathetic system(Epinephrine, Norepinephrine, Cortisol)
Time Frame: Change from baseline to 4 hours And repeated 1 week later
ng/ml
Change from baseline to 4 hours And repeated 1 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tehran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmadreza Dorosty Motlagh, PhD, Tehran University of Medical Sciences, Tehran, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90-04-27-15366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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