UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035855
Receipt No. 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 (Ver. 4)

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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
Last 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
Email akinoriyaegashidesu@gmail.com

Public contact
1st 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
Email akinoriyaegashidesu@gmail.com

Sponsor
Institute Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040843