UMIN-CTR Clinical Trial

Public title

Effects of sugar derivatives on sleep

Acronym

Effects of sugar derivatives on sleep

Scientific Title

Effects of sugar derivatives on sleep

Scientific Title:Acronym

Effects of sugar derivatives on sleep

Region

Japan

Condition

not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the ripple effect of improving sleep when adult men and women with sleep problems or dissatisfaction consume the test food.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1) Evaluate the daily changes in the occurrence rate of non-REM sleep stage 3 (N3), an objective index of sleep quantity and quality obtained from the sleep measurement results of each subject, during (1) the pre-measurement period and (2) the first, second, fourth and eighth week of intake of the test and target foods, during each sleep evaluation period, when the changes are stable. Calculate the average value for the latter 3 to 2 nights. Differences or changes in these averages between the test and control foods during each intake period will be evaluated using a linear mixed model, etc. (significance level: p < 0.05).

Key secondary outcomes

(1) Various objective indices of sleep quantity and quality (total sleep time, sleep efficiency, sleep latency, time awake after falling asleep, time on the floor after last awakening, total time or rate of occurrence of each sleep stage, delta-power, etc.) obtained from the sleep measurement results of each subject are evaluated for (1) the pre-measurement period and (2) the first, second, fourth and eighth weeks of consumption of the test and target foods. The daily changes during each sleep evaluation period of (1) the pre-measurement period, (2) Week 1, (3) Week 2, (4) Week 4, (5) Week 8, and (6) Week 8 will be evaluated and the average values for the last 3 to 2 nights when the changes are stable will be calculated. Differences or changes in these averages between the test and control foods during each intake period will be evaluated using linear mixed models, etc. (significance level: p < 0.05).
(2) Evaluate the daily changes in the subjective sleep quality parameters scored on the MA version of the OSA Sleep Questionnaire for each subject during (1) the pre-measurement period and (2) the first, second, fourth, and eighth week of consumption of the test and target foods, and calculate the average value during the latter three to two nights when changes are stable (iii) Weeks 1, 2, 3, 4, and 8 of the intake period. The differences between the test and control foods in these averages during each intake period will be evaluated by t-test.
(3) If differences between the test food and the control food are found in the scores of parameters related to the quality and quantity of sleep and each factor of subjective evaluation, the differences between the test food and the control food in the amount of activity, autonomic nervous activity, stress, brain health, and fatigue will also be evaluated to analyze the factors and spillover effects.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of test foods for 8 weeks

Interventions/Control_2

Placebo (control food) for 8 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Healthy Japanese men and women who are between 20 and 80 years of age at the time of consent
(2) Those who have problems with sleep quality
(3) Persons who have been fully informed of the purpose and content of the study and who have signed a consent form prior to the start of the study.

Key exclusion criteria

(1) Who is currently receiving treatment (including medication) for any disease
(2) In particular, those who have been diagnosed with sleep disorders such as insomnia or sleep apnea and are taking drugs such as sleep inducing drugs or insomnia medications (including OTC drugs as well as prescription drugs) or receiving treatment with CPAP, mouthpiece, etc.
(3) In particular, those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, etc.
(4) In particular, those who suffer from post-coronary syndrome
(5) Those who regularly consume Food for Specified Health Use, Food with Functional Labeling, or other food/beverage with possible functionality
(6) Those whose BMI exceeds 30 (severely obese)
(7) Those who are mainly in charge of taking care of those who need nursing care or infants
(8) Those who work late at night, shift work, or heavy labor
(9) Those who are pregnant, lactating, or intend to become pregnant
(10) Those who cannot sleep alone on a single bedding (futon or bed, etc.) during the examination period.
(11) Those who are not able to comply with the gentle sleep control (going to bed within +-2 hours of the declared bedtime and waking up within +-2 hours of the declared waking time) during the examination period, or those who are not sleeping regularly.

Items that cannot be listed in the key exclusion criterria column are listed in other related information.

Target sample size

260

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Sakurai

Organization

Clinical Creative Corporation

Division name

Pharmaceuticals Division

Zip code

353-0001

Address

4-1-37 Kamimuneoka, Shiki-shi, Saitama

TEL

090-6700-4850

Email

s-sakurai@cli-creative.com

Name of contact person

1st name	Ryosuke
Middle name
Last name	Kataoka

Organization

Clinical Creative Corporation

Division name

Pharmaceuticals Division

Zip code

061-1121

Address

6-1-3 Chuo, Kitahiroshima-shi, Hokkaido

TEL

090-3076-5054

Homepage URL

Email

r-kataoka@cli-creative.com

Institute

Clinical Creative Corporation

Institute

Department

Personal name

Organization

TFC Research Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Sokujinkai Kitahiroshima Hospital Clinical Trial Review Committee

Address

6-2-2 Chuo, Kitahiroshima-shi, Hokkaido

Tel

011-373-5811

Email

kanribukeiri@sokujinkai.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

03

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

10

Month

20

Day

Date of IRB

2023

Year

01

Month

16

Day

Anticipated trial start date

2023

Year

03

Month

10

Day

Last follow-up date

2023

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(12) Those who are at high risk of nocturia
(13) Patients who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6 p.m. during the EEG measurement period and the day before
(14) Consistently consumes alcohol in excess of the appropriate level (average daily alcohol consumption of approximately 20 g of pure alcohol or less*).
(15) Those who engage in extremely low levels of activity and exercise during the day
(16) Persons who are unable to follow the schedule for EEG measurement and entry into the sleep diary and OSA Sleep Questionnaire
(17) Participated in another clinical trial in the month prior to the date of consent or will participate in another clinical trial during the study period
(18) Have traveled abroad within 2 weeks of the date of consent or plan to travel abroad during the study period
(19) Do not have a smartphone
(20) Those who are unable to install the Fitbit application on their smartphones
(21) Other participants who are deemed by the physician to be inappropriate to participate in the study.
*About 1 medium beer bottle, 1 gou of sake, half a gou of shochu, a double whiskey/brandy, 1.5 glasses of wine, or 1.5 cans of chuhai

Registered date

2023

Year

01

Month

19

Day

Last modified on

2024

Year

07

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057048