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Riboflavin and thiamine dietary nutrition supplementation or reduction of anxiety, stress condition and improvement of sleep quality: A randomized double-blind, placebo-controlled trial

Association between thiamine (vitamin B1) and riboflavin (vitamin B2) nutrition intervention on anxiety, stress and sleep quality

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096497
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Anxiety, stress, sleep disorders

Interventions

VB1&VB2 group:Vitamin B1 and vitamin B2 health supplement tablets each contain 100mg of vitamin B1 or vitamin B2
Placebo group:The placebo group received two sucrose tablets with the same appearance, smell, color, taste, and packaging as the vitamin B1 and vitamin B2 supplements.

Sponsors

Macau University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Interested participants were first screened on-site and required to meet the following inclusion criteria: 1) age 18-25 years; 2) Self-Rating Anxiety Scale (SAS) score of at least 50; 3) Perceived Stress Scale (PSS) score at least 13; 4) Pittsburgh Sleep Quality Index (PSQI) score of at least 6; 5) score at least 6 on the Epworth Sleepiness Scale (Epworth Sleepiness Scale).

Exclusion criteria

Exclusion criteria: Individuals with 1) BMI less than 18.5 and more than 40 kg/m^2 were excluded from this study; 2) the content of vitamin B1 in urine is more than 200ug, and the content of vitamin B2 in urine is more than 800ug; 3) individuals experiencing stress such as bankruptcy, love failure, and a history of death within the past six months in first-degree relatives and close friends. 4) with neurological or organic diseases; 5) pathological anxiety (e.g., generalized anxiety disorder (GAD)) or psychiatric disorders (e.g., post-traumatic stress disorder); Individuals diagnosed with inflammatory diseases and other specific diseases such as diabetes, cardiovascular disease, cancer, hypertension, renal disease, liver disease, hyperthyroidism, epilepsy, and MS. 6) diagnosed with a pathologic sleep disorder (e.g., severe insomnia, severe obstructive sleep apnea syndrome); 7) recent history of alcohol or drug use (past 3 months); 8) pregnant or lactating women. In addition, subjects who failed to complete the questionnaire and correctly followed the instructions were excluded.

Design outcomes

Primary

MeasureTime frame
Vitamin B1 and vitamin B2 nutritional levels;Anxiety scale score;Stress scale score;Sleep QUALITY SCORE;

Countries

China

Contacts

Public ContactXi Yu

Macao University of Science and Technology

xyu@must.edu.mo+86 185 2961 2565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026