Investigate Beneficial Effect of Herbal Tea in Jordanian Adults (herbaltea)

September 14, 2019 updated by: Dr.Ruba Musharbash

Beneficial Effects of Herbal Tea on Lipid Profile, Insulin Resistance, CRP, CBC, Liver, and Kidney Function Tests, and Anthropometric Indices in Jordanian Adults

investigate beneficial effect of an herbal tea prepared from carob pulp and pods (Ceratonia siliqua), anise seed (Pimpinella Anisum L), wild thyme, green tea and eucalyptus leaves with Manuka honey (natural sweetener) on lipid profile and insulin resistance, CRP (C-reactive protein), CBC (complete blood count), liver function test, kidney function tests, inflammation and anthropometric indices in adults living in Amman Jordan

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

This study will be carried out to examine the effect of herbal tea in recruited subjects in an intervention single-group pretest-posttest study for a period of 7 weeks. Subjects will consume twice a day for a period of 7 weeks an herbal tea of (carob, anise, wild thyme, and eucalyptus leaves) before eating. The total sample (n=30) adults aged (19-57 years) , body mass index BMI range (19-35 kg/m2)

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 (Actual)

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.
30

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

  • Jordan
      • Amman, Jordan
        • Ruba Musharbash

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

19 years to 57 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults aged 19-57 years
  • male to female ratio (1:1 ratio)
  • BMI 19-35 kg/m2
  • Currently living in Amman
  • without significant apparent diseases
  • Able to drink the tested herbal tea twice a day

Exclusion Criteria:

  • Have chronic diseases such as diabetes, hypertension, cardiovascular or endocrine diseases or disabilities
  • Using medical drugs and/or supplements
  • Below 19 or above 57 years.
  • participation in clinical trials within the last 2 months
  • use of lipid-lowering drugs, or diabetic medication.
  • Lactating and pregnant women will be also excluded.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: adults aged 19-57
adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57
Other: herbal tea intervention
herbal tea intervention for 7 weeks
Other Names:
  • anise
  • herbal tea
  • carob
  • green tea
  • manuka honey
  • wild thyme
  • eucalyptus leaves

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
Questionnaire
Time Frame: 1-2 weeks
basic demographic information
1-2 weeks
Homocysteine serum level
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by umol/L normal range < 12 umol/L
7 weeks pre and post intervention
Fasting blood sugar
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range 70-99 mg/dL
7 weeks pre and post intervention
Glycosylated Haemoglobin (HBA1C) blood
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by percentage normal range 4.8-5.8%
7 weeks pre and post intervention
Cholesterol serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range <200 mg/dL
7 weeks pre and post intervention
Triglyceride serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range <150 mg/dL
7 weeks pre and post intervention
HDL cholesterol(High density lipoprotein) serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range >60mg/dL
7 weeks pre and post intervention
Cholesterol/HDL Ratio
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates normal range <4.0
7 weeks pre and post intervention
LDL Cholesterol (low density lipoprotein) serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range <100mg/dL
7 weeks pre and post intervention
Protein serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by g/dL normal range 6.0-8.0g/dL
7 weeks pre and post intervention
C-Reactive Protein high sensitivity serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL , low risk of CVD <1.0 mg/dL
7 weeks pre and post intervention
Insulin serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by uU/ml normal range 2.6-24.9
7 weeks pre and post intervention
Cortisol Total (AM) serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by ug/dL normal range 6.02-18.4
7 weeks pre and post intervention
Tumor Necrosis Factor
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by pg/mL normal range upto 8.1
7 weeks pre and post intervention
8-OH-2 Desoxyyguanosine urine
Time Frame: 7 weeks pre and post intervention
Urine sample measured by micromol/mol normal range 0.1-2.4
7 weeks pre and post intervention
interleukin 1 Beta
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by pg/ml normal range upto 5 pg/ml
7 weeks pre and post intervention
weight
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kg
7 weeks pre and post intervention
Height
Time Frame: pre intervention
measured by cm
pre intervention

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
gastrointestinal symptoms questionnaire
Time Frame: 7 weeks pre and post intervention
measure severity of GI symptoms including bloating , flatulence, gastrointestinal pain and loss of appetite, measure the occurrence of these symptoms and reduction in mean severity symptoms after herbal intervention
7 weeks pre and post intervention
Creatinine serum
Time Frame: 7 weeks pre and post intervention
venous blood sample for 30 candidates measured by mg/dL normal range male 0.7-1.2mg/dL females 0.5-0.9mg/dL
7 weeks pre and post intervention
Alanine Aminotransferase (ALT/GPT) serum
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by U/L normal range Upto 41 U/L
7 weeks pre and post intervention
Aspartate Aminotransferase (AST/GOT) serum
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by U/L normal range Upto 40 U/L
7 weeks pre and post intervention
Gamma-Glutamyl Transferase (GGT) serum
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by U/L normal range 8-61 U/L
7 weeks pre and post intervention
Alkaline phosphatase serum
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by U/L normal range 40-129
7 weeks pre and post intervention
Creatine phospho Kinase (CPK)
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by U/L normal range males 20-200 U/L females 20-180 U/L
7 weeks pre and post intervention
Microalbuminuria spot urine
Time Frame: 7 weeks pre and post intervention
Urine sample measured by mg/L normal range <20.0 mg/L
7 weeks pre and post intervention
Creatinine spot urine
Time Frame: 7 weeks pre and post intervention
Urine sample measured by mg/dL normal range males 39-259 mgd/L females 28-217mg/dL
7 weeks pre and post intervention
Microalbuminuria-Creatinine spot urine
Time Frame: 7 weeks pre and post intervention
Urine sample measured by by mg/g creat. normal range < 30.0 mg/g creat.
7 weeks pre and post intervention
Haemoglobin
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by gm/L males 140-180 gm/L females 120-160 gm/L
7 weeks pre and post intervention
haematocrit
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by L/L males 0.42-0.54L/L females 0.37-0.47 L/L
7 weeks pre and post intervention
Erythrocytes
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by x10^12/L males 4.7-6.1 x10^12/L females 4.2-5.4 x10^12/L
7 weeks pre and post intervention
MCV
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by FL normal range 80-96 FL
7 weeks pre and post intervention
MCH
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by pg normal range 27-31 pg
7 weeks pre and post intervention
MCHC
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by gm/L normal range 320-360gm/L
7 weeks pre and post intervention
RDW- cv
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by percentage normal range 11.5-14.5%
7 weeks pre and post intervention
Leukocytes
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by x10^9/L normal range 4.500-10.000
7 weeks pre and post intervention
platelets
Time Frame: 7 weeks pre and post intervention
Venous blood sample for 30 candidates measured by x10^9/L normal range 150-400
7 weeks pre and post intervention
Skeletal muscle mass
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kg
7 weeks pre and post intervention
Body fat mass
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kg
7 weeks pre and post intervention
Percent body fat mass
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by percentage
7 weeks pre and post intervention
free fat muscle
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kg
7 weeks pre and post intervention
Visceral fat are
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by cm2
7 weeks pre and post intervention
total body water
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by L
7 weeks pre and post intervention
Body mass index
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kg/m2
7 weeks pre and post intervention
Basal metabolic rate
Time Frame: 7 weeks pre and post intervention
measured on inbody 770 measured by kcal
7 weeks pre and post intervention
waist circumference
Time Frame: 7 weeks pre and post intervention
measured by cm measures using measuring tape
7 weeks pre and post intervention
Hip circumference
Time Frame: 7 weeks pre and post intervention
measured by cm measures using measuring tape
7 weeks pre and post intervention
Waist/hip ratio
Time Frame: 7 weeks pre and post intervention
measured using equation waist/hip
7 weeks pre and post intervention
Waist/height ratio
Time Frame: 7 weeks pre and post intervention
measured using equation waist/height
7 weeks pre and post intervention

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.
Dr.Ruba Musharbash

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 (Actual)

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.
June 1, 2019

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.
November 30, 2019

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.
January 30, 2020

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 19, 2019

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.
September 14, 2019

First Posted (Actual)

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.
September 17, 2019

Study Record Updates

Last Update Posted (Actual)

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.
September 17, 2019

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.
September 14, 2019

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.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 1762019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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