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Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

Not Applicable
Conditions
Diet, Healthy
Interventions
Other: herbal tea intervention
Registration Number
NCT04093128
Lead Sponsor
Dr.Ruba Musharbash
Brief 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

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)

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
adults aged 19-57herbal tea interventionadults aged 19-57 years old living in Amman Jordan, body mass index between 19-57
Primary Outcome Measures
NameTimeMethod
Questionnaire1-2 weeks

basic demographic information

Homocysteine serum level7 weeks pre and post intervention

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

Fasting blood sugar7 weeks pre and post intervention

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

Glycosylated Haemoglobin (HBA1C) blood7 weeks pre and post intervention

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

Cholesterol serum7 weeks pre and post intervention

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

Triglyceride serum7 weeks pre and post intervention

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

HDL cholesterol(High density lipoprotein) serum7 weeks pre and post intervention

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

Cholesterol/HDL Ratio7 weeks pre and post intervention

venous blood sample for 30 candidates normal range \<4.0

Protein serum7 weeks pre and post intervention

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

C-Reactive Protein high sensitivity serum7 weeks pre and post intervention

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

Insulin serum7 weeks pre and post intervention

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

Cortisol Total (AM) serum7 weeks pre and post intervention

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

Tumor Necrosis Factor7 weeks pre and post intervention

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

8-OH-2 Desoxyyguanosine urine7 weeks pre and post intervention

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

interleukin 1 Beta7 weeks pre and post intervention

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

weight7 weeks pre and post intervention

measured on inbody 770 measured by kg

Heightpre intervention

measured by cm

LDL Cholesterol (low density lipoprotein) serum7 weeks pre and post intervention

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

Secondary Outcome Measures
NameTimeMethod
gastrointestinal symptoms questionnaire7 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

Creatinine serum7 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

Alanine Aminotransferase (ALT/GPT) serum7 weeks pre and post intervention

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

Aspartate Aminotransferase (AST/GOT) serum7 weeks pre and post intervention

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

Gamma-Glutamyl Transferase (GGT) serum7 weeks pre and post intervention

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

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

Microalbuminuria spot urine7 weeks pre and post intervention

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

Creatinine spot urine7 weeks pre and post intervention

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

Alkaline phosphatase serum7 weeks pre and post intervention

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

Microalbuminuria-Creatinine spot urine7 weeks pre and post intervention

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

Haemoglobin7 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

haematocrit7 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

Erythrocytes7 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

MCV7 weeks pre and post intervention

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

MCH7 weeks pre and post intervention

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

MCHC7 weeks pre and post intervention

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

RDW- cv7 weeks pre and post intervention

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

Leukocytes7 weeks pre and post intervention

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

platelets7 weeks pre and post intervention

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

Skeletal muscle mass7 weeks pre and post intervention

measured on inbody 770 measured by kg

Body fat mass7 weeks pre and post intervention

measured on inbody 770 measured by kg

Percent body fat mass7 weeks pre and post intervention

measured on inbody 770 measured by percentage

free fat muscle7 weeks pre and post intervention

measured on inbody 770 measured by kg

Visceral fat are7 weeks pre and post intervention

measured on inbody 770 measured by cm2

total body water7 weeks pre and post intervention

measured on inbody 770 measured by L

Body mass index7 weeks pre and post intervention

measured on inbody 770 measured by kg/m2

Basal metabolic rate7 weeks pre and post intervention

measured on inbody 770 measured by kcal

waist circumference7 weeks pre and post intervention

measured by cm measures using measuring tape

Hip circumference7 weeks pre and post intervention

measured by cm measures using measuring tape

Waist/hip ratio7 weeks pre and post intervention

measured using equation waist/hip

Waist/height ratio7 weeks pre and post intervention

measured using equation waist/height

Trial Locations

Locations (1)

Ruba Musharbash

🇯🇴

Amman, Jordan

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