Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

Dr.Ruba Musharbash30 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diet, Healthy

Interventions

herbal tea interventionOTHER

herbal tea intervention for 7 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 57 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ruba Musharbash

Amman, Jordan

Outcomes

Primary Outcomes

Questionnaire

basic demographic information

Time frame: 1-2 weeks

Homocysteine serum level

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

Time frame: 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

Time frame: 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%

Time frame: 7 weeks pre and post intervention

Cholesterol serum

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

Time frame: 7 weeks pre and post intervention

Triglyceride serum

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

Time frame: 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

Time frame: 7 weeks pre and post intervention

Cholesterol/HDL Ratio

venous blood sample for 30 candidates normal range \<4.0

Time frame: 7 weeks pre and post intervention

LDL Cholesterol (low density lipoprotein) serum

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 7 weeks pre and post intervention

Alkaline phosphatase serum

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

Time frame: 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

Time frame: 7 weeks pre and post intervention

Microalbuminuria spot urine

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 7 weeks pre and post intervention

MCV

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

Time frame: 7 weeks pre and post intervention

MCH

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

Time frame: 7 weeks pre and post intervention

MCHC

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

Time frame: 7 weeks pre and post intervention

RDW- cv

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

Time frame: 7 weeks pre and post intervention

Leukocytes

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

platelets

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

Time frame: 7 weeks pre and post intervention

Skeletal muscle mass

measured on inbody 770 measured by kg

Time frame: 7 weeks pre and post intervention

Body fat mass

measured on inbody 770 measured by kg

Time frame: 7 weeks pre and post intervention

Percent body fat mass

measured on inbody 770 measured by percentage

Time frame: 7 weeks pre and post intervention

free fat muscle

measured on inbody 770 measured by kg

Time frame: 7 weeks pre and post intervention

Visceral fat are

measured on inbody 770 measured by cm2

Time frame: 7 weeks pre and post intervention

total body water

measured on inbody 770 measured by L

Time frame: 7 weeks pre and post intervention

Body mass index

measured on inbody 770 measured by kg/m2

Time frame: 7 weeks pre and post intervention

Basal metabolic rate

measured on inbody 770 measured by kcal

Time frame: 7 weeks pre and post intervention

waist circumference

measured by cm measures using measuring tape

Time frame: 7 weeks pre and post intervention

Hip circumference

measured by cm measures using measuring tape

Time frame: 7 weeks pre and post intervention

Waist/hip ratio

measured using equation waist/hip

Time frame: 7 weeks pre and post intervention

Waist/height ratio

measured using equation waist/height

Time frame: 7 weeks pre and post intervention