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A study to evaluate a dietary supplement on improving sleep quality and mood states

The effects of supplementation with Maizinol (Zea mays, corn grass extract) on mood state, sleep quality, and associated metabolic parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68282897
Enrollment
45
Registered
2021-09-21
Start date
2020-05-20
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Improvements in mood and sleep quality in healthy participants Not Applicable

Interventions

After a 2 week baseline period of no supplementation, participants will be allocated at random in a 1:1:1 ratio to each of the three study groups: 1. Group A: to take a supplement of 2

Sponsors

Unigen Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy adults aged =18 years 2. Able to provide informed consent 3. Ability/desire to participate in a 6-week long study with a 4-week supplementation regimen and sleep quality study

Exclusion criteria

Exclusion criteria: 1. Inability to complete prescribed supplement regimen 2. Current use of incompatible medications or supplements 3. High use of caffeine (<500 mg/day) or other stimulants 4. Off shift and night shift workers 5. Diagnosed with severe sleep disorders

Design outcomes

Primary

MeasureTime frame
Data were collected on the following parameters, twice during baseline (prior to supplementation) and at 1, 2, 3, 4, 5, and 6 weeks: 1. Salivary cortisol level measured using saliva samples 2. Mental well-being and psychological mood state measured using the Profile of Mood States survey (POMS) 3. Sleep quality was measured using both: 3.1. The Garmin Viviosmart® 4 fitness activity tracker which includes advanced sleep monitoring with REM sleep, light sleep, deep sleep, and movement throughout the night 3.2. The validated Pittsburgh Sleep Quality Index (PSQI)

Secondary

MeasureTime frame
Salivary cortisol level measured using saliva samples at 4 weeks

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026