UMIN ID: UMIN000054239
Registered date:30/04/2024
Effects of natural honey intake on glucose metabolism in type 2 diabetes mellitus
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
| Date of first enrollment | 2024/05/13 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Duration of intervention 1) Intake of snacks mainly consisting of carbohydrates (4 weeks) 2) Consumption of natural honey as a substitute for snacks (4 weeks) Amount and number of interventions The intake amount, timing, and number of intakes of natural honey and snacks will be determined depending on experience during non-examination periods. |
Outcome(s)
| Primary Outcome | Non-inferiority of the change in glycoalbumin (GA) during the natural honey substitute intake period against the change in GA during the regular snack intake period. |
|---|---|
| Secondary Outcome | 1) Non-inferiority in the change in HbA1c during the natural honey substitute intake period compared to the change in HbA1c during the regular snack intake period. 2) Regarding the following factors, perform statistical analysis on changes in the regular snack consumption period and the natural honey substitute consumption period. (Weight, BMI, hemogram, blood cell counts (white blood cell differential), Total cholesterol (TC), LDL-C, HDL-C, TG, total protein, albumin, creatinine, eGFR, uric acid, AST(GOT), ALT(GPT), GGT, total bilirubin, fasting blood glucose level, fasting blood insulin, fasting blood C-peptide, HbA1c, glycoalbumin (GA), hs-CRP, AGE sensor measurements. 3) Histogram evaluation and variance analysis of the snack intake satisfaction survey results. 4) Perform other comprehensive analyzes as necessary. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | bbb |
Related Information
| Primary Sponsor | Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | No |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takeshi Matsumura |
| Address | 1-1-1 Honjyo, Chuo, Kumamoto, Kumamoto, Japan Japan 860-8556 |
| Telephone | 0963735169 |
| takeshim@gpo.kumamoto-u.ac.jp | |
| Affiliation | Faculty of Life Sciences, Kumamoto University Department of Metabolic Medicine |
| scientific contact | |
| Name | Takeshi Matsumura |
| Address | 1-1-1 Honjyo, Chuo, Kumamoto, Kumamoto, Japan Japan |
| Telephone | 0963735169 |
| takeshim@gpo.kumamoto-u.ac.jp | |
| Affiliation | Kumamoto University Department of Metabolic Medicine, Faculty of life sciences |