Effect of a Dietary Supplement on Quality of Life

NCT05323084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-16

Study results available
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Summary

The purpose of this research study is to evaluate the effect of a combination of 3 food components to improve the quality of life in people who have trouble sleeping. Ten subjects with insomnia will drink 2 ounces of the supplement or a placebo for 1 week and after a 2 weeks washout period, will take the treatment they did not take the first week. Questionnaires to evaluate quality of life, and a sleep study will be done before and after each treatment week.

Conditions

  • Quality of Life

Interventions

DIETARY_SUPPLEMENT

Dietary supplement

1 week of each intervention at bedtime with a 2-week washout period in between interventions

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER
  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Paula R Brantley, PhD · Pennington Biomedical Research Center Institutional Review Board

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2022-09-07
Completion
2022-09-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323084 on ClinicalTrials.gov