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Diet, HealthyherbalteaNCT04093128

Investigate Beneficial Effect of Herbal Tea in Jordanian Adults

A study testing herbal tea intervention in people with Diet, Healthy, run by Dr.Ruba Musharbash at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 19 to 57 yearsHealthy volunteers can take part
Conditions the study is for
Diet, Healthy
What is being tested?
herbal tea intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJordan
Study dates
1 Jun 2019to 30 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 57 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Ruba Musharbash

    Amman

Other trials in Jordan

About this study

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

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

Read the 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)

Conditions
Diet, Healthy
Being tested
herbal tea intervention
Keywords
herbal tea, infusion, carob, green tea, anise, insulin resistance, inflammation, health, lipid profile, manuka honey
Medical subject headings
Insulin Resistance, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • herbal tea interventionOther

    Also called herbal tea, carob, anise, green tea

    herbal tea intervention for 7 weeks

Study groups in NCT04093128
Study groupRoleWhat they receive
adults aged 19-57Experimentaladults aged 19-57 years old living in Amman Jordan, body mass index between 19-57
Receives: Other: herbal tea intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Questionnaire

    basic demographic information

    Measured: 1-2 weeks

  2. Homocysteine serum level

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

    Measured: 7 weeks pre and post intervention

  3. Fasting blood sugar

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

    Measured: 7 weeks pre and post intervention

  4. Glycosylated Haemoglobin (HBA1C) blood

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

    Measured: 7 weeks pre and post intervention

  5. Cholesterol serum

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

    Measured: 7 weeks pre and post intervention

  6. Triglyceride serum

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

    Measured: 7 weeks pre and post intervention

  7. HDL cholesterol(High density lipoprotein) serum

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

    Measured: 7 weeks pre and post intervention

  8. Cholesterol/HDL Ratio

    venous blood sample for 30 candidates normal range <4.0

    Measured: 7 weeks pre and post intervention

  9. LDL Cholesterol (low density lipoprotein) serum

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

    Measured: 7 weeks pre and post intervention

  10. Protein serum

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

    Measured: 7 weeks pre and post intervention

  11. C-Reactive Protein high sensitivity serum

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

    Measured: 7 weeks pre and post intervention

  12. Insulin serum

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

    Measured: 7 weeks pre and post intervention

  13. Cortisol Total (AM) serum

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

    Measured: 7 weeks pre and post intervention

  14. Tumor Necrosis Factor

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

    Measured: 7 weeks pre and post intervention

  15. 8-OH-2 Desoxyyguanosine urine

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

    Measured: 7 weeks pre and post intervention

  16. interleukin 1 Beta

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

    Measured: 7 weeks pre and post intervention

  17. weight

    measured on inbody 770 measured by kg

    Measured: 7 weeks pre and post intervention

  18. Height

    measured by cm

    Measured: pre intervention

Secondary outcomes (31)

  1. 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

    Measured: 7 weeks pre and post intervention

  2. 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

    Measured: 7 weeks pre and post intervention

  3. Alanine Aminotransferase (ALT/GPT) serum

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

    Measured: 7 weeks pre and post intervention

  4. Aspartate Aminotransferase (AST/GOT) serum

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

    Measured: 7 weeks pre and post intervention

  5. Gamma-Glutamyl Transferase (GGT) serum

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

    Measured: 7 weeks pre and post intervention

  6. Alkaline phosphatase serum

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

    Measured: 7 weeks pre and post intervention

  7. 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

    Measured: 7 weeks pre and post intervention

  8. Microalbuminuria spot urine

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

    Measured: 7 weeks pre and post intervention

  9. Creatinine spot urine

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

    Measured: 7 weeks pre and post intervention

  10. Microalbuminuria-Creatinine spot urine

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

    Measured: 7 weeks pre and post intervention

  11. Haemoglobin

    Venous blood sample for 30 candidates measured by gm/L males 140-180 gm/L females 120-160 gm/L

    Measured: 7 weeks pre and post intervention

  12. haematocrit

    Venous blood sample for 30 candidates measured by L/L males 0.42-0.54L/L females 0.37-0.47 L/L

    Measured: 7 weeks pre and post intervention

  13. 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

    Measured: 7 weeks pre and post intervention

  14. MCV

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

    Measured: 7 weeks pre and post intervention

  15. MCH

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

    Measured: 7 weeks pre and post intervention

  16. MCHC

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

    Measured: 7 weeks pre and post intervention

  17. RDW- cv

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

    Measured: 7 weeks pre and post intervention

  18. Leukocytes

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

    Measured: 7 weeks pre and post intervention

  19. platelets

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

    Measured: 7 weeks pre and post intervention

  20. Skeletal muscle mass

    measured on inbody 770 measured by kg

    Measured: 7 weeks pre and post intervention

  21. Body fat mass

    measured on inbody 770 measured by kg

    Measured: 7 weeks pre and post intervention

  22. Percent body fat mass

    measured on inbody 770 measured by percentage

    Measured: 7 weeks pre and post intervention

  23. free fat muscle

    measured on inbody 770 measured by kg

    Measured: 7 weeks pre and post intervention

  24. Visceral fat are

    measured on inbody 770 measured by cm2

    Measured: 7 weeks pre and post intervention

  25. total body water

    measured on inbody 770 measured by L

    Measured: 7 weeks pre and post intervention

  26. Body mass index

    measured on inbody 770 measured by kg/m2

    Measured: 7 weeks pre and post intervention

  27. Basal metabolic rate

    measured on inbody 770 measured by kcal

    Measured: 7 weeks pre and post intervention

  28. waist circumference

    measured by cm measures using measuring tape

    Measured: 7 weeks pre and post intervention

  29. Hip circumference

    measured by cm measures using measuring tape

    Measured: 7 weeks pre and post intervention

  30. Waist/hip ratio

    measured using equation waist/hip

    Measured: 7 weeks pre and post intervention

  31. Waist/height ratio

    measured using equation waist/height

    Measured: 7 weeks pre and post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start1 Jun 2019
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion30 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093128
Sponsor's protocol ID
1762019
Acronym
herbaltea
Status last verified
Sep 2019
First submitted
19 Jul 2019
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing herbal tea intervention in people with Diet, Healthy, run by Dr.Ruba Musharbash at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire (time frame: 1-2 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04093128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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