Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

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Abstract

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

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)

Dates

Last Verified:	08/31/2019
First Submitted:	07/18/2019
Estimated Enrollment Submitted:	09/13/2019
First Posted:	09/16/2019
Last Update Submitted:	09/13/2019
Last Update Posted:	09/16/2019
Actual Study Start Date:	05/31/2019
Estimated Primary Completion Date:	11/29/2019
Estimated Study Completion Date:	01/29/2020

Condition or disease

Diet, Healthy

Intervention/treatment

Other: adults aged 19-57

Phase

Arm Groups

Arm	Intervention/treatment
Experimental: adults aged 19-57 adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57	Other: adults aged 19-57 herbal tea intervention for 7 weeks

Eligibility Criteria

Ages Eligible for Study	19 Years To 19 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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.

Outcome

Primary Outcome Measures

1. Questionnaire [1-2 weeks]

basic demographic information

2. Homocysteine serum level [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by umol/L normal range < 12 umol/L

3. Fasting blood sugar [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL normal range 70-99 mg/dL

4. Glycosylated Haemoglobin (HBA1C) blood [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by percentage normal range 4.8-5.8%

5. Cholesterol serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL normal range <200 mg/dL

6. Triglyceride serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL normal range <150 mg/dL

7. HDL cholesterol(High density lipoprotein) serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL normal range >60mg/dL

8. Cholesterol/HDL Ratio [7 weeks pre and post intervention]

venous blood sample for 30 candidates normal range <4.0

9. LDL Cholesterol (low density lipoprotein) serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL normal range <100mg/dL

10. Protein serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by g/dL normal range 6.0-8.0g/dL

11. C-Reactive Protein high sensitivity serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by mg/dL , low risk of CVD <1.0 mg/dL

12. Insulin serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by uU/ml normal range 2.6-24.9

13. Cortisol Total (AM) serum [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by ug/dL normal range 6.02-18.4

14. Tumor Necrosis Factor [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by pg/mL normal range upto 8.1

15. 8-OH-2 Desoxyyguanosine urine [7 weeks pre and post intervention]

Urine sample measured by micromol/mol normal range 0.1-2.4

16. interleukin 1 Beta [7 weeks pre and post intervention]

venous blood sample for 30 candidates measured by pg/ml normal range upto 5 pg/ml

17. weight [7 weeks pre and post intervention]

measured on inbody 770 measured by kg

18. Height [pre intervention]

measured by cm

Secondary Outcome Measures

1. gastrointestinal symptoms questionnaire [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

2. Creatinine serum [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

3. Alanine Aminotransferase (ALT/GPT) serum [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by U/L normal range Upto 41 U/L

4. Aspartate Aminotransferase (AST/GOT) serum [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by U/L normal range Upto 40 U/L

5. Gamma-Glutamyl Transferase (GGT) serum [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by U/L normal range 8-61 U/L

6. Alkaline phosphatase serum [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by U/L normal range 40-129

7. Creatine phospho Kinase (CPK) [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

8. Microalbuminuria spot urine [7 weeks pre and post intervention]

Urine sample measured by mg/L normal range <20.0 mg/L

9. Creatinine spot urine [7 weeks pre and post intervention]

Urine sample measured by mg/dL normal range males 39-259 mgd/L females 28-217mg/dL

10. Microalbuminuria-Creatinine spot urine [7 weeks pre and post intervention]

Urine sample measured by by mg/g creat. normal range < 30.0 mg/g creat.

11. Haemoglobin [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

12. haematocrit [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

13. Erythrocytes [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

14. MCV [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by FL normal range 80-96 FL

15. MCH [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by pg normal range 27-31 pg

16. MCHC [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by gm/L normal range 320-360gm/L

17. RDW- cv [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by percentage normal range 11.5-14.5%

18. Leukocytes [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by x10^9/L normal range 4.500-10.000

19. platelets [7 weeks pre and post intervention]

Venous blood sample for 30 candidates measured by x10^9/L normal range 150-400

20. Skeletal muscle mass [7 weeks pre and post intervention]

measured on inbody 770 measured by kg

21. Body fat mass [7 weeks pre and post intervention]

measured on inbody 770 measured by kg

22. Percent body fat mass [7 weeks pre and post intervention]

measured on inbody 770 measured by percentage

23. free fat muscle [7 weeks pre and post intervention]

measured on inbody 770 measured by kg

24. Visceral fat are [7 weeks pre and post intervention]

measured on inbody 770 measured by cm2

25. total body water [7 weeks pre and post intervention]

measured on inbody 770 measured by L

26. Body mass index [7 weeks pre and post intervention]

measured on inbody 770 measured by kg/m2

27. Basal metabolic rate [7 weeks pre and post intervention]

measured on inbody 770 measured by kcal

28. waist circumference [7 weeks pre and post intervention]

measured by cm measures using measuring tape

29. Hip circumference [7 weeks pre and post intervention]

measured by cm measures using measuring tape

30. Waist/hip ratio [7 weeks pre and post intervention]

measured using equation waist/hip

31. Waist/height ratio [7 weeks pre and post intervention]

measured using equation waist/height

Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

Keywords

breckland thyme

inflammation

insulin resistance

pimpinella

pimpinella anisum

leptospermum

leptospermum scoparium

camellia sinensis

camellia

thymus

thymus vulgaris

sweeteners

Abstract

Description

Dates

Condition or disease

Intervention/treatment

Phase

Arm Groups

Eligibility Criteria

Outcome

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