UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041481 |
|---|---|
| Receipt number | R000047340 |
| Scientific Title | Effects of wet and dry intermittent fasting on weight status and cardiovascular disease risk indicators in overweight women: A randomized cross-over trial |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2020/08/20 16:44:13 |
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Basic information
Public title
A randomized cross-over trial to determine the effects of wet and dry intermittent fasting on weight status and cardiovascular disease risk indicators in overweight women
Acronym
Comparing wet IF and dry IF
Scientific Title
Effects of wet and dry intermittent fasting on weight status and cardiovascular disease risk indicators in overweight women: A randomized cross-over trial
Scientific Title:Acronym
Comparing wet IF and dry IF
Region
| Asia(except Japan) |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of wet fasting and dry fasting on weight and cardiovascular disease risk indicators in overweight women in a 9-day cross over clinical trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum lipid profile changes
Key secondary outcomes
Change of body weight, waist circumference
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
14: 10 Wet intermittent fasting (14 hours of fasting and eating 50% of Total energy requirement in the remaining 10 hours)
Interventions/Control_2
14: 10 dry intermittent fasting (14 hours of fasting and eating 50% of Total energy requirement in the remaining 10 hours)
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
age 18 to 59 y, overweight, non diabetic, apparently healthy, light to moderately active
Key exclusion criteria
history of metabolic disease, fasted any day in the last two weeks and took weight loss or lipid or glucose-lowering medications in the last two weeks
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fariha |
| Middle name | |
| Last name | Musharrat |
Organization
Institute of Nutrition and Food Science, University of Dhaka, Bangladesh
Division name
Dhaka
Zip code
1000
Address
Suhrawardi Udyan Rd, Dhaka 1000
TEL
+8801757929826
sreoty@gmail.com
Public contact
Name of contact person
| 1st name | Fariha |
| Middle name | |
| Last name | Musharrat |
Organization
Institute of Nutrition and Food Science, University of Dhaka, Bangladesh
Division name
Dhaka
Zip code
1000
Address
Suhrawardi Udyan Rd, Dhaka 1000
TEL
+8801757929826
Homepage URL
sreoty@gmail.com
Sponsor or person
Institute
Institute of Nutrition and Food Science, University of Dhaka, Bangladesh
Institute
Department
Personal name
Funding Source
Organization
Ministry of Science and Technology, People's Republic of Bangladesh
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Biological Science, University of Dhaka
Address
Suhrawardi Udyan Rd, Dhaka 1000
Tel
+88 09666911463
vcoffice@du.ac.bd
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
| 2020 | Year | 08 | Month | 20 | 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
20
Results
Both IF resulted in significant weight loss. The loss was significantly higher in dry IF subjects (p=0.045). Waist circumference was also significantly reduced (p=0.025). Among the blood pressures, only diastolic pressure changed significantly in dry fasting. Biochemical parameters (total cholesterol, triglycerides, HDL, LDL) did not change significantly within or between interventions.
Results date posted
| 2020 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After screening, 20 participants were randomly assigned to the interventions, and 18 participants (90.0% of those assigned) completed the study. One subject dropped out due to her time constraint, whereas another dropped out as she was diagnosed with pre-diabetes after the initial screening.
Participant flow
Randomly assigned to either wet fasting or dry fasting (1:1). After a washout period the intervention was altered for all of them.
Adverse events
None
Outcome measures
Change of body weight, waist circumference, blood pressure, serum lipid profiles (LDL, HDL, Total cholesterol, Triglyceride) etc
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047340
