Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

Diet, Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04093128
• Other study ID #: 1762019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2019
• Source: Ruba Musharbash Nutrition Consultancy Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 57 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Healthy
• Insulin Resistance

Intervention

Other:
• herbal tea intervention
herbal tea intervention for 7 weeks

Locations

Country	Name	City	State
Jordan	Ruba Musharbash	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Ruba Musharbash

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	basic demographic information	1-2 weeks
Primary	Homocysteine serum level	venous blood sample for 30 candidates measured by umol/L normal range < 12 umol/L	7 weeks pre and post intervention
Primary	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
Primary	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
Primary	Cholesterol serum	venous blood sample for 30 candidates measured by mg/dL normal range <200 mg/dL	7 weeks pre and post intervention
Primary	Triglyceride serum	venous blood sample for 30 candidates measured by mg/dL normal range <150 mg/dL	7 weeks pre and post intervention
Primary	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
Primary	Cholesterol/HDL Ratio	venous blood sample for 30 candidates normal range <4.0	7 weeks pre and post intervention
Primary	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
Primary	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
Primary	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
Primary	Insulin serum	venous blood sample for 30 candidates measured by uU/ml normal range 2.6-24.9	7 weeks pre and post intervention
Primary	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
Primary	Tumor Necrosis Factor	venous blood sample for 30 candidates measured by pg/mL normal range upto 8.1	7 weeks pre and post intervention
Primary	8-OH-2 Desoxyyguanosine urine	Urine sample measured by micromol/mol normal range 0.1-2.4	7 weeks pre and post intervention
Primary	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
Primary	weight	measured on inbody 770 measured by kg	7 weeks pre and post intervention
Primary	Height	measured by cm	pre intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Alkaline phosphatase serum	Venous blood sample for 30 candidates measured by U/L normal range 40-129	7 weeks pre and post intervention
Secondary	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
Secondary	Microalbuminuria spot urine	Urine sample measured by mg/L normal range <20.0 mg/L	7 weeks pre and post intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	MCV	Venous blood sample for 30 candidates measured by FL normal range 80-96 FL	7 weeks pre and post intervention
Secondary	MCH	Venous blood sample for 30 candidates measured by pg normal range 27-31 pg	7 weeks pre and post intervention
Secondary	MCHC	Venous blood sample for 30 candidates measured by gm/L normal range 320-360gm/L	7 weeks pre and post intervention
Secondary	RDW- cv	Venous blood sample for 30 candidates measured by percentage normal range 11.5-14.5%	7 weeks pre and post intervention
Secondary	Leukocytes	Venous blood sample for 30 candidates measured by x10^9/L normal range 4.500-10.000	7 weeks pre and post intervention
Secondary	platelets	Venous blood sample for 30 candidates measured by x10^9/L normal range 150-400	7 weeks pre and post intervention
Secondary	Skeletal muscle mass	measured on inbody 770 measured by kg	7 weeks pre and post intervention
Secondary	Body fat mass	measured on inbody 770 measured by kg	7 weeks pre and post intervention
Secondary	Percent body fat mass	measured on inbody 770 measured by percentage	7 weeks pre and post intervention
Secondary	free fat muscle	measured on inbody 770 measured by kg	7 weeks pre and post intervention
Secondary	Visceral fat are	measured on inbody 770 measured by cm2	7 weeks pre and post intervention
Secondary	total body water	measured on inbody 770 measured by L	7 weeks pre and post intervention
Secondary	Body mass index	measured on inbody 770 measured by kg/m2	7 weeks pre and post intervention
Secondary	Basal metabolic rate	measured on inbody 770 measured by kcal	7 weeks pre and post intervention
Secondary	waist circumference	measured by cm measures using measuring tape	7 weeks pre and post intervention
Secondary	Hip circumference	measured by cm measures using measuring tape	7 weeks pre and post intervention
Secondary	Waist/hip ratio	measured using equation waist/hip	7 weeks pre and post intervention
Secondary	Waist/height ratio	measured using equation waist/height	7 weeks pre and post intervention