The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult

The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult: a randomized, double-blind, placebo-controlled study - The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056743

Enrollment

Registered

2026-02-28

Start date

2025-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

To dissolve D-BHB-containing protein (D-BHB 2 g/day) in 200 ml of water and intake it for 4 weeks (28 days) To dissolve the placebo protein not containing D-BHB in 200 ml of water and intake it for 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) persons who is generally judged as healthy (2) Persons who can give voluntary written consent to participate in the present trial (3) Persons who are aware of their physical and mental fatigue and stress

Exclusion criteria

Exclusion criteria: (1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator

Design outcomes

Primary

Measure	Time frame
Fatigue visual analog scale The Depression Anxiety Stress Scales-21 Profile of Mood States 2 OSA sleep inventory MA version	—

Secondary

Measure	Time frame
Chalder Fatigue Scale	—

Countries

Japan

Contacts

Public ContactKeiko Ohnuki

User Life Science Co.,Ltd. The research and development part

userlifescience@gmail.com0948-82-3123

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026