UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054239 |
|---|---|
| Receipt number | R000061928 |
| Scientific Title | Effects of natural honey intake as a substitute eating between meals on glucose metabolism in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2024/04/23 19:15:20 |
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Basic information
Public title
Effects of natural honey intake on glucose metabolism in type 2 diabetes mellitus
Acronym
Naomi study
Scientific Title
Effects of natural honey intake as a substitute eating between meals on glucose metabolism in type 2 diabetes mellitus
Scientific Title:Acronym
NAOMI Study (Effects of NAtural hOney intake as a substitute eating between meals on glucose MetabolIsm in type 2 diabetes mellitus)
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In management of diabetes mellitus (DM), dietary therapy, especially guidance regarding snack intake, is an important issue in maintaining blood glucose control. In particular, consuming foods containing sugar, which are generally referred to as 'snacks', outside of meal times can lead to excessive intake and elevated blood glucose for patients with DM who have certain restrictions on carbohydrate and energy intake.
The main carbohydrate component of natural honey is fructose, and several reports suggest that its increasing effect of blood glucose is weaker than that of glucose or sucrose. However, little has been reported on the effects on glucose metabolism and the other metabolism when natural honey is used as an alternative to regular snacks.
The aim of this study was to investigate the effects of natural honey intake, as a substitute for regular carbohydrate-based snacking, on glucose metabolism in patients with T2DM.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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)
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
bbb
Key exclusion criteria
bbb
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumura |
Organization
Kumamoto University
Division name
Department of Metabolic Medicine, Faculty of life sciences
Zip code
860-8556
Address
1-1-1 Honjyo, Chuo, Kumamoto, Kumamoto, Japan
TEL
0963735169
takeshim@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
860-8556
Address
1-1-1 Honjyo, Chuo, Kumamoto, Kumamoto, Japan
TEL
0963735169
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Ethics Review Committee of Kumamoto University
Address
1-1-1 Honjyo, Chuo, Kumamoto, Kumamoto, Japan
Tel
0963735169
takeshim@gpo.kumamoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061928
