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

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: Unknown
• Conditions: Diet, Healthy
• Intervention / Treatment: Other: herbal tea intervention

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Ruba Musharbash

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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: 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

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

Collaborators and Investigators

• Sponsor: Dr.Ruba Musharbash

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: September 14, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: health; inflammation; insulin resistance; infusion; manuka honey; green tea; lipid profile; carob; herbal tea; anise
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID 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