UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035855 |
|---|---|
| Receipt number | R000040843 |
| Scientific Title | The effects on healthy volunteers consuming an evening-only low-carbohydrate meal |
| Date of disclosure of the study information | 2019/02/13 |
| Last modified on | 2019/05/01 13:34:16 |
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Basic information
Public title
The effects on healthy volunteers consuming an evening-only low-carbohydrate meal
Acronym
The effects on healthy volunteers consuming an evening-only low-carbohydrate meal
Scientific Title
The effects on healthy volunteers consuming an evening-only low-carbohydrate meal
Scientific Title:Acronym
The effects on healthy volunteers consuming an evening-only low-carbohydrate meal
Region
| Japan |
Condition
Condition
Healthy men(age range, 20-29 years)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of consuming an evening-only low-carbohydrate meal on biochemical measures of glucose and lipid metabolism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride(at fasting and 60, 120, 240 min after the start of the meal at 1800 h)
Key secondary outcomes
Glucose, insulin, active glucagon-like peptide-1, active glucose-dependent insulinotropic polypeptide, glucagon,non-high-density lipoprotein cholesterol, Interleukin-6, high sensitivity C-reactive protein
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The study was conducted for three consecutive days. Two types of diet were prescribed. The standard test meal consisted of 52% carbohydrate (100 g), 20% protein (40 g), 28% fat (25 g), and fiber 5 g. The low carbohydrate meal consisted of 11% carbohydrate (21 g), 31% protein (60 g), 58% fat (51 g), and fiber 4 g, On the first day, after overnight fasting, morning blood samples were collected, and measurements of height, weight, body composition, blood pressure, and pulse rate were obtained. Subsequently, the participants consumed the prescribed standard test meal at 1800 h. On the second day, the participants consumed the standard test meal at 0800 h and 1300 h, arrived at Tenshi College at 1700 h, and consumed the standard test meal at 1800 h. Blood samples were collected at fasting and 60, 120, 240 min after the start of the meal at 1800 h. On the third day, the dietary and blood sampling protocols were the same, except for consuming the low carbohydrate meal at 1800 h rather than the standard test meal.
Interventions/Control_2
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Non-smoking participants aged between 20 and 29 years
Key exclusion criteria
Individuals who worked late at night, who had a BMI 25 or more, who routinely took supplements, who had been previously diagnosed with a metabolic disease, who had a familial history of hypercholesterolemia, or who took corticosteroid medication.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Yaegashi |
Organization
Hokkaido Bunkyo University
Division name
Department of Health and Nutrition, Faculty of Human Science
Zip code
061-1449
Address
5-196-1 Kogane-chuo, Eniwa, Japan
TEL
0123-34-0019
akinoriyaegashidesu@gmail.com
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Yaegashi |
Organization
Hokkaido Bunkyo University
Division name
Department of Health and Nutrition, Faculty of Human Science
Zip code
061-1449
Address
5-196-1 Kogane-chuo, Eniwa Japan
TEL
0123-34-0019
Homepage URL
akinoriyaegashidesu@gmail.com
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Tenshi College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College
Address
1-30, Kita13 Jo Higashi 3 Chome, 1-30, Higashi-ku, Sapporo
Tel
011-741-1051
akinoriyaegashidesu@gmail.com
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
天使大学（北海道） Tenshi College(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Consuming an evening-only low carbohydrate meal at 1800 h was advantageous in that postprandial glucose, insulin, and active glucose-dependent insulinotropic polypeptide levels were suppressed, and the low carbohydrate meal promoted active glucagon-like peptide-1; however, triglycerides levels increased.
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
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040843
