Body Fat Disorder, Hyperlipidemias, Obesity
Conditions
Keywords
Chinese herbal medicine, Xian-Hua-Cha, hyperlipidemia, obesity, body fat
Brief summary
In the past decades, lipid and body fat disorders become a serious global healthcare issue, especially among the obese population. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to explore the efficacy of Xian-Hua-Cha (XHC) on relieving hyperlipidemia among obese patient. For this purpose, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are analyzed in the end of this study.
Detailed description
Recently, there are more and more studies show the natural herbal products can improve obesity and related metabolic disorders through changing the body composition and even body weight, but most of the studies are still at the phase of animal studies. In the ancient Chinese medical book Danxi's mastery of medicine mentioned Overweight people often have phlegm. From the past observational study, obesity is related phlegm, and the recent concept shows that obesity is a chronic inflammation disease. Therefore, we combined phlegm removal herbal medicine and Chinese medicine for clearing heat and detoxifying together for obese patients with lipid disorders in clinical practice. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to analyze the efficacy of Xian-Hua-Cha (XHC) on relieving hyperlipidemia among the obese population. For this reason, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are collected for analysis. Besides, we also record adverse effects from taking XHC to assess the safety of XHC.
Interventions
DRUGXian-Hua-Cha
Zizyphus jujuba Mill., Nelumbo nucifera Gaertn, Citrus reticulata Blanco, Rosa rugosa Thunb., Cassia obtusifolia L., Stevioside, resistant starch, and water
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
A number generated by random sequence before enrollment will be assigned to each subject to separate all subjects to two groups. Diet education/monitoring will be given with or without XHC depending the phase of trial course. Since XHC is a mixture of herbal products and difficult to make proper placebo, we adopt the crossover with open-label design in this study.
Intervention model description
All eligible subjects will be allocated randomly to 2 groups. Each group will have a 7-month course, including 3-month XHC treatment and 3-month no XHC treatment period (control). One month washout period will be arranged between these two 3-month treatment periods.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. BMI ≧ 27kg/m2 2. Total cholesterol \> 200 mg/dL or LDL \> 130 mg/dL or triglyceride \> 150 mg/dL 3. Age ≧ 20 years and \< 75 years 4. No recognition difficulties 5. Willing to sign inform consent and comply to protocol
Exclusion criteria
1. Pregnant or breast-feeding women 2. Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder) 3. Diagnosis of neurologic or psychiatric diseases 4. Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR \< 60 mL/min/1.73 m2) 5. Acute stress condition (severe infection, receive major surgery in the recent 1 month) 6. Vision, or hearing impairment 7. With other clinical trial medication 8. With medication for obesity or hyperlipidemia in the recent 1 month 9. Heavy smoker, alcoholism or substance abuse 10. Severe organ dysfunction: malignancies, autoimmune diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on serum lipid profile | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | The changes on serum triglyceride, total cholesterol, LDL (low-density lipoprotein) cholesterol, and HDL (high-density lipoprotein) cholesterol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on body weight | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | The changes on body weight and body mass index (BMI) |
| Changes on body fat composition | 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period) | The changes on percentage of body fat and visceral fat, waist to hip ratio, and waistline. |
Countries
Taiwan
Outcome results
None listed