Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Diet, Healthy

Intervention / Treatment
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* Other: herbal tea intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adults aged 19-57<br>adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57 | Other: herbal tea intervention<br>* herbal tea intervention for 7 weeks<br>* Other names: eucalyptus leaves;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | basic demographic information | 1-2 weeks | 
| Homocysteine serum level | venous blood sample for 30 candidates measured by umol/L normal range < 12 umol/L | 7 weeks pre and post intervention | 
| Fasting blood sugar | 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 | venous blood sample for 30 candidates measured by percentage normal range 4.8-5.8% | 7 weeks pre and post intervention | 
| Cholesterol serum | venous blood sample for 30 candidates measured by mg/dL normal range <200 mg/dL | 7 weeks pre and post intervention | 
| Triglyceride serum | 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 | venous blood sample for 30 candidates measured by mg/dL normal range >60mg/dL | 7 weeks pre and post intervention | 
| Cholesterol/HDL Ratio | venous blood sample for 30 candidates normal range <4.0 | 7 weeks pre and post intervention | 
| LDL Cholesterol (low density lipoprotein) serum | venous blood sample for 30 candidates measured by mg/dL normal range <100mg/dL | 7 weeks pre and post intervention | 
| Protein serum | 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 | 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 | 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 | 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 | 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 | Urine sample measured by micromol/mol normal range 0.1-2.4 | 7 weeks pre and post intervention | 
| interleukin 1 Beta | venous blood sample for 30 candidates measured by pg/ml normal range upto 5 pg/ml | 7 weeks pre and post intervention | 
| weight | measured on inbody 770 measured by kg | 7 weeks pre and post intervention | 
| Height | measured by cm | pre intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 weeks pre and post 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 | 7 weeks pre and post intervention | 
| Alanine Aminotransferase (ALT/GPT) serum | 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 | 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 | 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 | Venous blood sample for 30 candidates measured by U/L normal range 40-129 | 7 weeks pre and post intervention | 
| 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 | 7 weeks pre and post intervention | 
| Microalbuminuria spot urine | Urine sample measured by mg/L normal range <20.0 mg/L | 7 weeks pre and post intervention | 
| Creatinine spot urine | 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 | Urine sample measured by by mg/g creat. normal range < 30.0 mg/g creat. | 7 weeks pre and post intervention | 
| Haemoglobin | 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 | 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 | 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 | Venous blood sample for 30 candidates measured by FL normal range 80-96 FL | 7 weeks pre and post intervention | 
| MCH | Venous blood sample for 30 candidates measured by pg normal range 27-31 pg | 7 weeks pre and post intervention | 
| MCHC | Venous blood sample for 30 candidates measured by gm/L normal range 320-360gm/L | 7 weeks pre and post intervention | 
| RDW- cv | Venous blood sample for 30 candidates measured by percentage normal range 11.5-14.5% | 7 weeks pre and post intervention | 
| Leukocytes | Venous blood sample for 30 candidates measured by x10^9/L normal range 4.500-10.000 | 7 weeks pre and post intervention | 
| platelets | Venous blood sample for 30 candidates measured by x10^9/L normal range 150-400 | 7 weeks pre and post intervention | 
| Skeletal muscle mass | measured on inbody 770 measured by kg | 7 weeks pre and post intervention | 
| Body fat mass | measured on inbody 770 measured by kg | 7 weeks pre and post intervention | 
| Percent body fat mass | measured on inbody 770 measured by percentage | 7 weeks pre and post intervention | 
| free fat muscle | measured on inbody 770 measured by kg | 7 weeks pre and post intervention | 
| Visceral fat are | measured on inbody 770 measured by cm2 | 7 weeks pre and post intervention | 
| total body water | measured on inbody 770 measured by L | 7 weeks pre and post intervention | 
| Body mass index | measured on inbody 770 measured by kg/m2 | 7 weeks pre and post intervention | 
| Basal metabolic rate | measured on inbody 770 measured by kcal | 7 weeks pre and post intervention | 
| waist circumference | measured by cm measures using measuring tape | 7 weeks pre and post intervention | 
| Hip circumference | measured by cm measures using measuring tape | 7 weeks pre and post intervention | 
| Waist/hip ratio | measured using equation waist/hip | 7 weeks pre and post intervention | 
| Waist/height ratio | measured using equation waist/height | 7 weeks pre and post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herbal tea, infusion, carob, green tea, anise, insulin resistance, inflammation, health, lipid profile, manuka honey