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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name