Curcuminoid supplementation on type 2 diabetes
| ISRCTN | ISRCTN85826075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85826075 |
| Secondary identifying numbers | 2009007 |
- Submission date
- 03/10/2010
- Registration date
- 25/10/2010
- Last edited
- 16/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Changhao Sun
Scientific
Scientific
157 Baojian Road
Nangang District
Harbin
150081
China
| Phone | +86 (0)451 8750 2801 |
|---|---|
| sun2002changhao@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Effects of curcuminoids on blood glucose, lipids, serum adipocyte fatty acid-binding protein and lipoprotein lipase in patients with type 2 diabetes: a double-blind, placebo-controlled trial |
| Study objectives | The natural compounds curcuminoids, including curcumin, demethoxycurcumin and bisdemethoxycurcumin, have a broad spectrum of health benefits including hypolipidemic, hypoglycemic effects. As diabetes is associated with impaired lipid metabolism, the improvement of lipid profile may explain at least in part the benefits of curcuminoids on diabetes. Our previous study confirmed that curcumin improved insulin resistance in part by decreasing plasma FFAs and increasing fatty acid oxidation in skeletal muscle of diabetic rats. However, reports about the effect of curcuminoids on type 2 diabetes in human are extremely limited. We hypothesized that curcuminoids would increase insulin sensitivity partly by promoting fatty acid oxidation in patients with type 2 diabetes. |
| Ethics approval(s) | Medical Ethics Committe of Public Health College, Harbin Medical University, approved on 20th September 2009 (ref: 2009007) |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Eligible subjects were first sorted by blood glucose concentration and then randomised into two groups with a block size of 2, with random numbers generated by SPSS. The subjects in the curcuminoids group received a 150 mg curcuminoid capsule twice daily (30 minutes after breakfast and supper respectively) for a total intake of 300 mg/d curcuminoids (the purity had been confirmed to be 97.49% by HPLC: curcumin 36.06%; demethoxycurcumin, 18.85%; bisdemethoxycurcumin, 42.58%). The subjects in placebo group took capsules with placebo (starch) instead of curcuminoids at the same frequency and amount. The intervention lasted for 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Curcuminoids |
| Primary outcome measure | 1. The effects of curcuminoids on glucose metabolism: fasting glucose and insulin, 2-hour post prandial glucose , HOMA-IR and HbA1c(%) 2. The effects of curcuminoids on lipis metabolism: 2.1. Serum cholesterol, triacylglycerol, HDL-C, LDL-C, Apo A-I and Apo B 2.2. Serum LPL and AFABP 2.3. Serum FFA profile 2.4. Severity of fatty liver |
| Secondary outcome measures | 1. Baseline characteristics: age, gender, BMI, waist circumference, waist-to-hip ratio, diabetes duration, blood pressure, drug treatment, cigarette use and physical activity level 2. Daily intake of nutrients by the subjects at baseline and after 3-month intervention 3. Blood biochemistry characteristics of the subjects at baseline and after 3-month intervention: red blood cell, white blood cell, hemoglobin, total protein, albumin, urea nitrogen, creatinine, alanine transaminase and aspartate transminase |
| Overall study start date | 10/10/2009 |
| Completion date | 10/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 18 - 65 years, both male and female 2. Type 2 diabetes with fasting blood glucose greater than or equal to 7.0 mmol/L or postprandial blood glucose greater than or equal to 11.1 mmol/L 3. Current optimal therapeutic regimens lasting for at least 6 months |
| Key exclusion criteria | 1. A history of type 1 diabetes, malignancies, thyroid or any other endocrine diseases likely to interfere with the study 2. Diabetic ketosis acidosis and infection in recent 3 months 3. Pregnancy or breastfeeding 4. Information incompleted or unwillingness to attempt to comply with the intervention |
| Date of first enrolment | 10/10/2009 |
| Date of final enrolment | 10/01/2010 |
Locations
Countries of recruitment
- China
Study participating centre
157 Baojian Road
Harbin
150081
China
150081
China
Sponsor information
Public Health College - Harbin Medical University (China)
University/education
University/education
c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China
| Phone | +86 (0)451 8750 2801 |
|---|---|
| sun2002changhao@yahoo.com | |
| Website | http://yxzy.hrbmu.edu.cn/gongwei/ |
"ROR" |
https://ror.org/05jscf583 |
Funders
Funder type
Government
National Natural Science Foundation of China (China) (ref: 30810107)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
National High Technology Research and Development Program of China (China) - 863 program) (ref: 2010AA023002)
No information available
Scientific Research Fund of Heilongjiang Provincial Education Department (China) (ref: 1154z1007)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2014 | 16/05/2022 | Yes | No |
Editorial Notes
16/05/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
