Curcuminoid supplementation on type 2 diabetes

ISRCTN	ISRCTN85826075
DOI	https://doi.org/10.1186/ISRCTN85826075
Protocol serial number	2009007
Sponsor	Public Health College - Harbin Medical University (China)
Funders	National Natural Science Foundation of China (China) (ref: 30810107), National High Technology Research and Development Program of China (China) - 863 program) (ref: 2010AA023002), Scientific Research Fund of Heilongjiang Provincial Education Department (China) (ref: 1154z1007)

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

157 Baojian Road
Nangang District
Harbin
150081
China

Phone	+86 (0)451 8750 2801
Email	sun2002changhao@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Curcuminoids
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	10/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.