Effects of suvorexant on energy metabolism.

JRCT ID: jRCTs031210023

Registered date:07/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy male
• Date of first enrollment: 18/06/2021
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Oral administration of Suvorexant 20 mg to healthy subjects.

Outcome(s)

• Primary Outcome: The primary endpoint is the effect of suvorexant administration on 8-hour sleep energy expenditure, fatty acid formation and carbohydrate oxidation. The effect of suvorexant administration on the time course of energy metabolism after bedtime is analyzed by linear mixed ANOVA of hourly mean values of energy expenditure (kcal / h), fatty acidification (kcal / h) and carbohydrate oxidation (kcal / h).
• Secondary Outcome: To investigate the effect of suvorexant administration on overnight sleep architecture. Specifically, t-test for total sleep time (minutes), sleep efficiency (%), sleep onset latency (minutes), REM sleep latency (minutes), sleep stages N1, N2, N3 and R (minutes). consider. Suvorexant administration for energy metabolism (energy consumption (kcal / h), fatty acid formation (kcal / h) and carbohydrate oxidation (kcal / h)) at each sleep stage, considering that sleep energy metabolism is affected by sleep stages. The effect of this is compared with the placebo administration conditions and examined by t-test. The energy metabolism for each sleep stage is calculated using the method announced by the applicants 7). In addition, the effect of suvorexant administration on sleep core body temperature will be investigated.

Key inclusion & exclusion criteria

• Age minimum: > 19age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) The subjects whose age is 20 to 40 years old.
2) The subjects who have received sufficient explanation about this experiment, understood the contents well, and agreed to participate.

Exclude criteria

1) Subjects with a systolic blood pressure of 90 mmHg or less
2) Subjects who under any of the following indexes
a) Those who have heart, liver, kidney, stomach (including hyperacidity and gastric urcer) diseases.
b) Those with history of cardiovascular disease.
c) Those with intestinal disease and history of intestinal disease.
d) Those with digestive system disease and history of gastrointestinal surgery.
e) Those with dysphagia.
f) Those expecting to take a MRI.
g) Those with diabetes.
h) Those with thyroid disease.
i) Those with allergic to test substance.
j) Those with allergic to drugs.
3) Subjects with a history of significant liver dysfunction, renal dysfunction, or cardiovascular disease
4) Subjects who have been treated for mental illness or sleep disorders in the past, subjects who have symptoms to be treated now
5) Subjects who have electronic devices embedded in their bodies such as pacemakers.
6) Subjects who are lean (BMI less than 18.5 or weigh 36.3 kg or less) or obese (BMI 25 or more)
7) Subjects with claustrophobia
8) Subjects who are participating in other exams as test subjects or who have participated within 4 weeks after the end of the test
9) Subjects who are judged by the investigator to be inappropriate for the examination
10) Subjects who regularly use pharmaceuticals, foods for specified health use, foods with functional claims, health foods, etc.
11) Subjects who drink habitually (40 g of pure alcohol [approximate: 2 cans of beer] or more drink twice a week or more
12) Subjects who have a smoking habit
13) Subjects with a daily intake of caffeine of 300 mg (approximate: 5 cups of 150 mL coffee) or more
14) Subjects who have irregularly wake/sleep cycle(regular life: bedtime 21:00 to 1:00, wake up 6:00 to 9:00, sleep time 7 to 9 hours)
15) Subjects who have been engaged in night shift (after 22:00) within the past 3 months
16) Subjects who have traveled to a country with a time difference of 3 hours or more within the past 3 months
17) Subjects who score 30 points or less (clear night type) or 70 points or more (clear morning) on the morning/night type questionnaire
18) Subjects who have a score of 11 or more on the Epworth Sleepiness Scale
19) Subjects with a score of 5.5 or higher on the Pittsburgh Sleep Questionnaire

Related Information

• Primary Sponsor: Ichiyou Matsuzaki
• Source(s) of Monetary Support: Japan Society for the Promotion of Science