NCT01643096

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 15, 2012

Last Update Submit

July 16, 2012

Conditions

Effects of; Food, Allergic

Keywords

Zataria multiflora Boiss Sumac TEF temperament

Outcome Measures

Primary Outcomes (1)

  • Thermic Effect of Food (TEF)

    kilocalorie(kcal) and by indirect calorimetery

    Change from baseline to 4 hours And repeated 1 week later

Secondary Outcomes (1)

  • activity of sympathetic - parasympathetic system(Epinephrine, Norepinephrine, Cortisol)

    Change from baseline to 4 hours And repeated 1 week later

Study Arms (2)

sumac

OTHER

Thermic effect of food of Sumac and comparison between hot and cold temperament people

Other: Sumac

Zataria multiflora Boiss

OTHER

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

Other: Zataria multiflora Boiss

Interventions

Zataria multiflora BoissOTHER

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

Also known as: Thyme
Zataria multiflora Boiss
SumacOTHER

Thermic effect of food of Sumac and comparison between hot and cold temperament people

Also known as: sumach
sumac

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

Study Officials

  • Ahmadreza Dorosty Motlagh, PhD

    Tehran University of Medical Sciences, tehran, iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2012

First Posted

July 17, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2014

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

IR(1)