Effect of a Dietary Supplement on Quality of Life

NCT05323084 | Completed Results

• 1 other identifier: PBRC 2020-039
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Chubon Lifestyle Score

  Total score ranges from 20 to 140 with higher scores being better quality of life

  1 week

Secondary Outcomes (5)

• Pittsburgh Sleep Quality Index Score

  1 week

• Epworth Sleepiness Scale

  1 week

• Multidimensional Fatigue Index -General Fatigue

  1-week

• Multidimensional Fatigue Index - Physical Fatigue

  1 week

• Multidimensional Fatigue Index - Mental Fatigue

  1 week

Other Outcomes (3)

• Sleep Latency

  1-week

• Wake After Sleep Onset

  1-week

• Sleep Efficiency

  1-week

Study Arms (2)

Dietary supplement

EXPERIMENTAL

Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor

Dietary Supplement: Dietary supplement

Placebo

PLACEBO COMPARATOR

60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor

Dietary Supplement: Dietary supplement

Interventions

Dietary supplement DIETARY_SUPPLEMENT

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

Also known as: Placebo

Dietary supplement; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men or women \>50 years of age
• Usual bedtime between 9pm and midnight
• Insomnia for \>6months by ICSD-2 criteria
• Insomnia Severity Index score \>10 and Sleep-onset latency or Waking after sleep onset \>30 minutes

You may not qualify if:

• Have diabetes mellitus
• Taking chronic medication not on a stable dose for \>1month
• Taking sedating or hypnotic medications
• Have a sleep disorder other than insomnia (like sleep apnea) Adults unable to consent Prisoners Pregnant women Individuals not yet adults

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

Related Links

• Chubon Quality of Life Rating,
• Validation of the Insomnia Severity Index
• Epworth Sleepiness scale
• Pittsburgh Sleep Quality Index

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Prachi Singh
• Organization: Pennington Biomedical Research Institute

prachi.singh@pbrc.edu

15072068331

Study Officials

• Paula R Brantley, PhD

  Pennington Biomedical Research Center Institutional Review Board

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Liquid that looks and tastes the same, but only one has the three food components. The order in which the subjects get the 3-component supplement and the placebo is randomly assigned and balanced.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Medical Officer

Model Details: 1 week of treatment with a three component supplement or a placebo in people with insomina on two occasions separated by a 2-week washout

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 12, 2022
• Study Start: February 25, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: December 16, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Study is expected to be done and report generated by June 2022
• Access Criteria: Data can be accessed, if the use is approved by the PI

Locations

US (1)