Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

NCT04093128 | Unknown

• 1 other identifier: 1762019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Diet, Healthy

Keywords

herbal tea; infusion; carob; green tea; anise; insulin resistance; inflammation; health; lipid profile; manuka honey

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (31)

• gastrointestinal symptoms questionnaire

  7 weeks pre and post intervention

• Creatinine serum

  7 weeks pre and post intervention

• Alanine Aminotransferase (ALT/GPT) serum

  7 weeks pre and post intervention

• Aspartate Aminotransferase (AST/GOT) serum

  7 weeks pre and post intervention

• Gamma-Glutamyl Transferase (GGT) serum

  7 weeks pre and post intervention

Study Arms (1)

adults aged 19-57

EXPERIMENTAL

adults aged 19-57 years old living in Amman Jordan, body mass index between 19-57

Other: herbal tea intervention

Interventions

herbal tea intervention OTHER

herbal tea intervention for 7 weeks

Also known as: herbal tea, carob, anise, green tea, manuka honey, wild thyme, eucalyptus leaves

adults aged 19-57

Eligibility Criteria

• Age: 19 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.Ruba Musharbash: lead

Study Sites (1)

Ruba Musharbash

Amman, Jordan

Location

MeSH Terms

Conditions

Insulin Resistance; Inflammation

Interventions

Teas, Herbal; locust bean gum; anise oil; Tea

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: September 17, 2019
• Study Start: June 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: January 30, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)