UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060249 |
|---|---|
| Receipt number | R000068913 |
| Scientific Title | Effects of Aerobic Exercise and Camel Milk Supplementation, Separately and Combined, on Glycemic Control in Postmenopausal Women with Type 2 Diabetes: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/04 |
| Last modified on | 2026/01/03 18:29:52 |
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Basic information
Public title
Effects of Aerobic Exercise and Camel Milk Supplementation, Separately and Combined, on Glycemic Control in Postmenopausal Women with Type 2 Diabetes: A Randomized Controlled Trial
Acronym
Effects of Aerobic Exercise and Camel Milk Supplementation,in Type 2 Diabetes
Scientific Title
Effects of Aerobic Exercise and Camel Milk Supplementation, Separately and Combined, on Glycemic Control in Postmenopausal Women with Type 2 Diabetes: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Aerobic Exercise and Camel Milk Supplementation,in Type 2 Diabetes
Region
| Asia(except Japan) |
Condition
Condition
women diabetic type2
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Aerobic Exercise and Camel Milk Supplementation, on Fasting Blood Sugar in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on Hemoglobin A1c in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on Insulin Resistance in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on body composition in Postmenopausal Women with Type 2 Diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting Blood Sugar
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention was conducted over 10 weeks. Group A (Camel Milk + Exercise) consumed 250 mL of fresh camel milk daily (sourced from local herds with veterinary approval) four days a week (on training days) while simultaneously performing aerobic exercise three sessions per week.
Interventions/Control_2
Group B (Camel Milk Only) consumed 250 mL of fresh camel milk daily for 10 weeks.
Interventions/Control_3
Group C (Exercise Only) performed only the aerobic exercise three sessions per week.
Interventions/Control_4
Group D (Control) received no intervention and participated only in the measurement sessions.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Inclusion criteria included natural menopause (12 months without menstruation), age 40 to 65 years, medical diagnosis of T2DM for at least 2 years, non-use of injectable insulin (oral treatment only), no regular physical activity in the past 6 months, non-smoker status, absence of orthopedic or mobility restrictions, and provision of written informed consent.
Key exclusion criteria
Exclusion criteria included having cardiovascular diseases, uncontrolled hypertension, kidney or liver failure, use of medications affecting glucose metabolism (other than standard diabetes drugs), non-adherence to the protocol (missing more than 2 training sessions or consuming less than 80% of the prescribed camel milk), and the occurrence of complications during the intervention (such as severe hypoglycemia or muscle injury).
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Ali |
| Middle name | |
| Last name | Younesian |
Organization
Shahrood University of Technology, Shahrood, Iran
Division name
sport physiology
Zip code
3619995161
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
TEL
982332392204
ayounesian@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Ali |
| Middle name | |
| Last name | Younesian |
Organization
shahrood university of technology
Division name
sport physiology
Zip code
3619995161
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
TEL
+982332392204
Homepage URL
ayounesian@shahroodut.ac.ir
Sponsor or person
Institute
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Address
Department of physical education,Shahrood University of Technology,Shahrood,Iran
Tel
+982332392204
ayounesian@shahroodut.ac.ir
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
| 2026 | Year | 01 | Month | 04 | 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
48
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068913
