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

Primary Purpose

Diet, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
herbal tea intervention
Sponsored by
Dr.Ruba Musharbash
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diet, Healthy focused on measuring herbal tea, infusion, carob, green tea, anise, insulin resistance, inflammation, health, lipid profile, manuka honey

Eligibility Criteria

19 Years - 57 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ruba Musharbash

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adults aged 19-57

Arm Description

adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2019
Last Updated
September 14, 2019
Sponsor
Dr.Ruba Musharbash
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1. Study Identification

Unique Protocol Identification Number
NCT04093128
Brief Title
Investigate Beneficial Effect of Herbal Tea in Jordanian Adults
Acronym
herbaltea
Official Title
Beneficial Effects of Herbal Tea on Lipid Profile, Insulin Resistance, CRP, CBC, Liver, and Kidney Function Tests, and Anthropometric Indices in Jordanian Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.Ruba Musharbash

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy
Keywords
herbal tea, infusion, carob, green tea, anise, insulin resistance, inflammation, health, lipid profile, manuka honey

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adults aged 19-57
Arm Type
Experimental
Arm Description
adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57
Intervention Type
Other
Intervention Name(s)
herbal tea intervention
Other Intervention Name(s)
herbal tea, carob, anise, green tea, manuka honey, wild thyme, eucalyptus leaves
Intervention Description
herbal tea intervention for 7 weeks
Primary Outcome Measure Information:
Title
Questionnaire
Description
basic demographic information
Time Frame
1-2 weeks
Title
Homocysteine serum level
Description
venous blood sample for 30 candidates measured by umol/L normal range < 12 umol/L
Time Frame
7 weeks pre and post intervention
Title
Fasting blood sugar
Description
venous blood sample for 30 candidates measured by mg/dL normal range 70-99 mg/dL
Time Frame
7 weeks pre and post intervention
Title
Glycosylated Haemoglobin (HBA1C) blood
Description
venous blood sample for 30 candidates measured by percentage normal range 4.8-5.8%
Time Frame
7 weeks pre and post intervention
Title
Cholesterol serum
Description
venous blood sample for 30 candidates measured by mg/dL normal range <200 mg/dL
Time Frame
7 weeks pre and post intervention
Title
Triglyceride serum
Description
venous blood sample for 30 candidates measured by mg/dL normal range <150 mg/dL
Time Frame
7 weeks pre and post intervention
Title
HDL cholesterol(High density lipoprotein) serum
Description
venous blood sample for 30 candidates measured by mg/dL normal range >60mg/dL
Time Frame
7 weeks pre and post intervention
Title
Cholesterol/HDL Ratio
Description
venous blood sample for 30 candidates normal range <4.0
Time Frame
7 weeks pre and post intervention
Title
LDL Cholesterol (low density lipoprotein) serum
Description
venous blood sample for 30 candidates measured by mg/dL normal range <100mg/dL
Time Frame
7 weeks pre and post intervention
Title
Protein serum
Description
venous blood sample for 30 candidates measured by g/dL normal range 6.0-8.0g/dL
Time Frame
7 weeks pre and post intervention
Title
C-Reactive Protein high sensitivity serum
Description
venous blood sample for 30 candidates measured by mg/dL , low risk of CVD <1.0 mg/dL
Time Frame
7 weeks pre and post intervention
Title
Insulin serum
Description
venous blood sample for 30 candidates measured by uU/ml normal range 2.6-24.9
Time Frame
7 weeks pre and post intervention
Title
Cortisol Total (AM) serum
Description
venous blood sample for 30 candidates measured by ug/dL normal range 6.02-18.4
Time Frame
7 weeks pre and post intervention
Title
Tumor Necrosis Factor
Description
venous blood sample for 30 candidates measured by pg/mL normal range upto 8.1
Time Frame
7 weeks pre and post intervention
Title
8-OH-2 Desoxyyguanosine urine
Description
Urine sample measured by micromol/mol normal range 0.1-2.4
Time Frame
7 weeks pre and post intervention
Title
interleukin 1 Beta
Description
venous blood sample for 30 candidates measured by pg/ml normal range upto 5 pg/ml
Time Frame
7 weeks pre and post intervention
Title
weight
Description
measured on inbody 770 measured by kg
Time Frame
7 weeks pre and post intervention
Title
Height
Description
measured by cm
Time Frame
pre intervention
Secondary Outcome Measure Information:
Title
gastrointestinal symptoms questionnaire
Description
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
Time Frame
7 weeks pre and post intervention
Title
Creatinine serum
Description
venous blood sample for 30 candidates measured by mg/dL normal range male 0.7-1.2mg/dL females 0.5-0.9mg/dL
Time Frame
7 weeks pre and post intervention
Title
Alanine Aminotransferase (ALT/GPT) serum
Description
Venous blood sample for 30 candidates measured by U/L normal range Upto 41 U/L
Time Frame
7 weeks pre and post intervention
Title
Aspartate Aminotransferase (AST/GOT) serum
Description
Venous blood sample for 30 candidates measured by U/L normal range Upto 40 U/L
Time Frame
7 weeks pre and post intervention
Title
Gamma-Glutamyl Transferase (GGT) serum
Description
Venous blood sample for 30 candidates measured by U/L normal range 8-61 U/L
Time Frame
7 weeks pre and post intervention
Title
Alkaline phosphatase serum
Description
Venous blood sample for 30 candidates measured by U/L normal range 40-129
Time Frame
7 weeks pre and post intervention
Title
Creatine phospho Kinase (CPK)
Description
Venous blood sample for 30 candidates measured by U/L normal range males 20-200 U/L females 20-180 U/L
Time Frame
7 weeks pre and post intervention
Title
Microalbuminuria spot urine
Description
Urine sample measured by mg/L normal range <20.0 mg/L
Time Frame
7 weeks pre and post intervention
Title
Creatinine spot urine
Description
Urine sample measured by mg/dL normal range males 39-259 mgd/L females 28-217mg/dL
Time Frame
7 weeks pre and post intervention
Title
Microalbuminuria-Creatinine spot urine
Description
Urine sample measured by by mg/g creat. normal range < 30.0 mg/g creat.
Time Frame
7 weeks pre and post intervention
Title
Haemoglobin
Description
Venous blood sample for 30 candidates measured by gm/L males 140-180 gm/L females 120-160 gm/L
Time Frame
7 weeks pre and post intervention
Title
haematocrit
Description
Venous blood sample for 30 candidates measured by L/L males 0.42-0.54L/L females 0.37-0.47 L/L
Time Frame
7 weeks pre and post intervention
Title
Erythrocytes
Description
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
Time Frame
7 weeks pre and post intervention
Title
MCV
Description
Venous blood sample for 30 candidates measured by FL normal range 80-96 FL
Time Frame
7 weeks pre and post intervention
Title
MCH
Description
Venous blood sample for 30 candidates measured by pg normal range 27-31 pg
Time Frame
7 weeks pre and post intervention
Title
MCHC
Description
Venous blood sample for 30 candidates measured by gm/L normal range 320-360gm/L
Time Frame
7 weeks pre and post intervention
Title
RDW- cv
Description
Venous blood sample for 30 candidates measured by percentage normal range 11.5-14.5%
Time Frame
7 weeks pre and post intervention
Title
Leukocytes
Description
Venous blood sample for 30 candidates measured by x10^9/L normal range 4.500-10.000
Time Frame
7 weeks pre and post intervention
Title
platelets
Description
Venous blood sample for 30 candidates measured by x10^9/L normal range 150-400
Time Frame
7 weeks pre and post intervention
Title
Skeletal muscle mass
Description
measured on inbody 770 measured by kg
Time Frame
7 weeks pre and post intervention
Title
Body fat mass
Description
measured on inbody 770 measured by kg
Time Frame
7 weeks pre and post intervention
Title
Percent body fat mass
Description
measured on inbody 770 measured by percentage
Time Frame
7 weeks pre and post intervention
Title
free fat muscle
Description
measured on inbody 770 measured by kg
Time Frame
7 weeks pre and post intervention
Title
Visceral fat are
Description
measured on inbody 770 measured by cm2
Time Frame
7 weeks pre and post intervention
Title
total body water
Description
measured on inbody 770 measured by L
Time Frame
7 weeks pre and post intervention
Title
Body mass index
Description
measured on inbody 770 measured by kg/m2
Time Frame
7 weeks pre and post intervention
Title
Basal metabolic rate
Description
measured on inbody 770 measured by kcal
Time Frame
7 weeks pre and post intervention
Title
waist circumference
Description
measured by cm measures using measuring tape
Time Frame
7 weeks pre and post intervention
Title
Hip circumference
Description
measured by cm measures using measuring tape
Time Frame
7 weeks pre and post intervention
Title
Waist/hip ratio
Description
measured using equation waist/hip
Time Frame
7 weeks pre and post intervention
Title
Waist/height ratio
Description
measured using equation waist/height
Time Frame
7 weeks pre and post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruba Musharbash
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

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