SleepNCT04499560
The Effects of a Nutrition Supplement on Health Related Quality of Life
A study testing Supplement Drink in people with Sleep and Stress, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Stress, Health, Subjective
- What is being tested?
- Supplement Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- otherwise healthy
- adults living in the US
- is practicing adequate contraception or is abstaining from all activities which could result in pregnancy
- understands and agrees to comply with study procedures
- provides informed consent
Who cannot join
- smoker
- pregnant or may become pregnant
- currently breastfeeding
- currently taking antioxidant supplements
- underlying chronic health conditions
- COVID-19 diagnosis
Show all 9Show fewer
- demonstrated inability to comply with study procedures
- history of allergy to citrus or berry fruits
- has participated in an interventional clinical study within 31 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin School of Integrative Health Sciences
Franklin, Tennessee, 37067
About this study
The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.
Read the detailed description
After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.
- Conditions
- Sleep, Stress, Health, Subjective, Inflammation, Cognitive Symptom
- Being tested
- Supplement Drink
- Keywords
- immune health, prevention, phytonutrients, superfoods, antioxidant, essential oils
- Medical subject headings
- Inflammation, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement DrinkDietary supplement
Superfoods based nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants consume 2 ounces of the supplement each morning for 60 days. Receives: Dietary Supplement: Supplement Drink |
| Control | No intervention | Participants do not make any changes to their health related routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.
Measured: Baseline and day 60
Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.
Measured: Baseline and day 60
Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.
Measured: Baseline and day 60
Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)
Measured: Day 60
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.
Measured: Baseline and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start3 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Young Living Essential Oils
- Responsible party
- Principal investigator, Jessie Hawkins, PhD, Nutraceuticals Research Institute
- Investigators
- Jessie Hawkins, PhD, Principal investigator, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499560
- Sponsor's protocol ID
- 20-7-1100
- Status last verified
- Feb 2021
- First submitted
- 30 Jul 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nutrition Supplement on Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT04499560
- Acronym / sponsor ID
- 20-7-1100
- Conditions
- Sleep, Stress, Health, Subjective, Inflammation, Cognitive Symptom
- Keywords
- immune health, prevention, phytonutrients, superfoods, antioxidant, essential oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Young Living Essential Oils
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.
Detailed description
After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Supplement DrinkParticipants consume 2 ounces of the supplement each morning for 60 days. |
| Control | No intervention | –Participants do not make any changes to their health related routines |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- otherwise healthy
- adults living in the US
- is practicing adequate contraception or is abstaining from all activities which could result in pregnancy
- understands and agrees to comply with study procedures
- provides informed consent
Key exclusion criteria (9 listed)
- smoker
- pregnant or may become pregnant
- currently breastfeeding
- currently taking antioxidant supplements
- underlying chronic health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement DrinkSuperfoods based nutritional supplement | Dietary supplement | Intervention |
Primary outcome
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
Time frame: Baseline and day 60
The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.
Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
Time frame: Baseline and day 60
The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.
Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
Time frame: Baseline and day 60
The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.
Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
Time frame: Day 60
The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
Time frame: Baseline and Day 60
The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie Hawkins, PhD principal investigator
Nutraceuticals Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement Drink in people with Sleep and Stress, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60 (time frame: Baseline and day 60). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.