Clinical trial NCT04093128: Investigate Beneficial Effect of Herbal Tea in Jordanian Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet, Healthy
Keywords: herbal tea
infusion
carob
green tea
anise
insulin resistance
inflammation
health
lipid profile
manuka honey
Lead sponsor: Ruba Musharbash Nutrition Consultancy Center
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility 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.

Primary outcomes:
measure: Questionnaire
timeFrame: 1-2 weeks
measure: Homocysteine serum level
timeFrame: 7 weeks pre and post intervention
measure: Fasting blood sugar
timeFrame: 7 weeks pre and post intervention
measure: Glycosylated Haemoglobin (HBA1C) blood
timeFrame: 7 weeks pre and post intervention
measure: Cholesterol serum
timeFrame: 7 weeks pre and post intervention
measure: Triglyceride serum
timeFrame: 7 weeks pre and post intervention
measure: HDL cholesterol(High density lipoprotein) serum
timeFrame: 7 weeks pre and post intervention
measure: Cholesterol/HDL Ratio
timeFrame: 7 weeks pre and post intervention
measure: LDL Cholesterol (low density lipoprotein) serum
timeFrame: 7 weeks pre and post intervention
measure: Protein serum
timeFrame: 7 weeks pre and post intervention
measure: C-Reactive Protein high sensitivity serum
timeFrame: 7 weeks pre and post intervention
measure: Insulin serum
timeFrame: 7 weeks pre and post intervention
measure: Cortisol Total (AM) serum
timeFrame: 7 weeks pre and post intervention
measure: Tumor Necrosis Factor
timeFrame: 7 weeks pre and post intervention
measure: 8-OH-2 Desoxyyguanosine urine
timeFrame: 7 weeks pre and post intervention
measure: interleukin 1 Beta
timeFrame: 7 weeks pre and post intervention
measure: weight
timeFrame: 7 weeks pre and post intervention
measure: Height
timeFrame: pre intervention
Secondary outcomes:
measure: gastrointestinal symptoms questionnaire
timeFrame: 7 weeks pre and post intervention
measure: Creatinine serum
timeFrame: 7 weeks pre and post intervention
measure: Alanine Aminotransferase (ALT/GPT) serum
timeFrame: 7 weeks pre and post intervention
measure: Aspartate Aminotransferase (AST/GOT) serum
timeFrame: 7 weeks pre and post intervention
measure: Gamma-Glutamyl Transferase (GGT) serum
timeFrame: 7 weeks pre and post intervention
measure: Alkaline phosphatase serum
timeFrame: 7 weeks pre and post intervention
measure: Creatine phospho Kinase (CPK)
timeFrame: 7 weeks pre and post intervention
measure: Microalbuminuria spot urine
timeFrame: 7 weeks pre and post intervention
measure: Creatinine spot urine
timeFrame: 7 weeks pre and post intervention
measure: Microalbuminuria-Creatinine spot urine
timeFrame: 7 weeks pre and post intervention
measure: Haemoglobin
timeFrame: 7 weeks pre and post intervention
measure: haematocrit
timeFrame: 7 weeks pre and post intervention
measure: Erythrocytes
timeFrame: 7 weeks pre and post intervention
measure: MCV
timeFrame: 7 weeks pre and post intervention
measure: MCH
timeFrame: 7 weeks pre and post intervention
measure: MCHC
timeFrame: 7 weeks pre and post intervention
measure: RDW- cv
timeFrame: 7 weeks pre and post intervention
measure: Leukocytes
timeFrame: 7 weeks pre and post intervention
measure: platelets
timeFrame: 7 weeks pre and post intervention
measure: Skeletal muscle mass
timeFrame: 7 weeks pre and post intervention
measure: Body fat mass
timeFrame: 7 weeks pre and post intervention
measure: Percent body fat mass
timeFrame: 7 weeks pre and post intervention
measure: free fat muscle
timeFrame: 7 weeks pre and post intervention
measure: Visceral fat are
timeFrame: 7 weeks pre and post intervention
measure: total body water
timeFrame: 7 weeks pre and post intervention
measure: Body mass index
timeFrame: 7 weeks pre and post intervention
measure: Basal metabolic rate
timeFrame: 7 weeks pre and post intervention
measure: waist circumference
timeFrame: 7 weeks pre and post intervention
measure: Hip circumference
timeFrame: 7 weeks pre and post intervention
measure: Waist/hip ratio
timeFrame: 7 weeks pre and post intervention
measure: Waist/height ratio
timeFrame: 7 weeks pre and post intervention
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ruba Musharbash
Study officials:
References: