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临床试验/NCT04093128
NCT04093128Unknown不适用

Beneficial Effects of Herbal Tea on Lipid Profile, Insulin Resistance, CRP, CBC, Liver, and Kidney Function Tests, and Anthropometric Indices in Jordanian Adults

Dr.Ruba Musharbash1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Questionnaire

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 57 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

adults aged 19-57

Experimental

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

干预措施: herbal tea intervention (Other)

结局指标

主要结局

Questionnaire

时间窗: 1-2 weeks

basic demographic information

Homocysteine serum level

时间窗: 7 weeks pre and post intervention

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

Fasting blood sugar

时间窗: 7 weeks pre and post intervention

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

Glycosylated Haemoglobin (HBA1C) blood

时间窗: 7 weeks pre and post intervention

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

Cholesterol serum

时间窗: 7 weeks pre and post intervention

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

Triglyceride serum

时间窗: 7 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) serum

时间窗: 7 weeks pre and post intervention

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

Cholesterol/HDL Ratio

时间窗: 7 weeks pre and post intervention

venous blood sample for 30 candidates normal range \<4.0

Protein serum

时间窗: 7 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 serum

时间窗: 7 weeks pre and post intervention

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

Insulin serum

时间窗: 7 weeks pre and post intervention

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

Cortisol Total (AM) serum

时间窗: 7 weeks pre and post intervention

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

Tumor Necrosis Factor

时间窗: 7 weeks pre and post intervention

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

8-OH-2 Desoxyyguanosine urine

时间窗: 7 weeks pre and post intervention

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

interleukin 1 Beta

时间窗: 7 weeks pre and post intervention

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

weight

时间窗: 7 weeks pre and post intervention

measured on inbody 770 measured by kg

Height

时间窗: pre intervention

measured by cm

LDL Cholesterol (low density lipoprotein) serum

时间窗: 7 weeks pre and post intervention

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

次要结局

  • 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)
  • Alkaline phosphatase serum(7 weeks pre and post intervention)
  • Creatine phospho Kinase (CPK)(7 weeks pre and post intervention)
  • Microalbuminuria spot urine(7 weeks pre and post intervention)
  • Creatinine spot urine(7 weeks pre and post intervention)
  • Microalbuminuria-Creatinine spot urine(7 weeks pre and post intervention)
  • Haemoglobin(7 weeks pre and post intervention)
  • haematocrit(7 weeks pre and post intervention)
  • Erythrocytes(7 weeks pre and post intervention)
  • MCV(7 weeks pre and post intervention)
  • MCH(7 weeks pre and post intervention)
  • MCHC(7 weeks pre and post intervention)
  • RDW- cv(7 weeks pre and post intervention)
  • Leukocytes(7 weeks pre and post intervention)
  • platelets(7 weeks pre and post intervention)
  • Skeletal muscle mass(7 weeks pre and post intervention)
  • Body fat mass(7 weeks pre and post intervention)
  • Percent body fat mass(7 weeks pre and post intervention)
  • free fat muscle(7 weeks pre and post intervention)
  • Visceral fat are(7 weeks pre and post intervention)
  • total body water(7 weeks pre and post intervention)
  • Body mass index(7 weeks pre and post intervention)
  • Basal metabolic rate(7 weeks pre and post intervention)
  • waist circumference(7 weeks pre and post intervention)
  • Hip circumference(7 weeks pre and post intervention)
  • Waist/hip ratio(7 weeks pre and post intervention)
  • Waist/height ratio(7 weeks pre and post intervention)

研究者

发起方
Dr.Ruba Musharbash
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.Ruba Musharbash

Principal investigator

Ruba Musharbash Nutrition Consultancy Center

研究点 (1)

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