Well-Being, PsychologicalNCT06603038
Perceived Wellbeing and Focus with Daily Greens Supplementation
A study testing Gainful Daily Performance Greens in people with Well-Being, Psychological, run by Gainful at 1 site in United States.
Trial summary
This study aims to investigate whether daily consumption of Gainful Daily Performance Greens for four weeks contributes to improved scores of wellbeing and focus in healthy adults, as compared to a control group of non-supplement takers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Gainful Daily Performance Greens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to 7 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently taking cognitive-enhancing supplements or medications
- Provide informed consent
- Have the ability to comply with the study protocol
Who cannot join
- Known allergy to the ingredients of Daily Performance Greens
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate whether daily consumption of Gainful Daily Performance Greens for four weeks contributes to improved scores of wellbeing and focus in healthy adults, as compared to a control group of non-supplement takers. The research question will be addressed by evaluating participants' responses using the World Health Organization's WHO-5 Wellbeing Index and the Mindful Attention Awareness Scale.
Read the detailed description
Purpose: The primary objective of this study is to assess the potential benefits of Gainful Daily Performance Greens on wellbeing and focus in healthy adults. The formulation of this supplement includes ingredients believed to support mental clarity and overall wellbeing. Understanding the impact of this product on subjective measures of wellbeing and focus will provide valuable insights into its potential benefits for a broader population.
Hypotheses: H0 (null hypothesis): There is no significant difference in wellbeing and focus scores between baseline and after four weeks of daily Gainful Daily Performance Greens consumption in healthy adults. H1 (alternate hypothesis): Daily consumption of Gainful Daily Performance Greens for four weeks results in improved scores of wellbeing and focus as measured by the WHO-5 Wellbeing Index and Mindful Attention Awareness Scale compared to baseline in healthy adults.
Goals and Objectives: The primary goal is to examine the potential positive effects of Gainful Daily Performance Greens on wellbeing and focus. Specific objectives include comparing pre- and post-supplementation scores using validated measures, identifying any changes in subjective experiences related to mental clarity and wellbeing, and exploring potential factors influencing individual responses.
Significance of Study: Understanding the impact of Gainful Daily Performance Greens on wellbeing and focus addresses the growing interest in functional foods and dietary supplements. If the study demonstrates positive effects, it may provide evidence for the inclusion of such supplements in promoting overall mental health and wellbeing in healthy adults.
Contribution to Field: This study contributes to the emerging field of nutritional interventions for overall wellbeing. By using established scales to measure wellbeing and focus, the research aims to provide valuable insights into the potential benefits of Gainful Daily Performance Greens, informing future research and dietary recommendations.
- Conditions
- Well-Being, Psychological
- Being tested
- Gainful Daily Performance Greens
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gainful Daily Performance GreensDietary supplement
Daily supplementation for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Supplementation with Daily Performance Greens daily for 28 days Receives: Dietary Supplement: Gainful Daily Performance Greens |
| Control | No intervention | Control group, no supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Wellbeing
Measured using WHO-5 Wellbeing Index Scale (0-5, where 5 is better outcome)
Measured: 28 days
Mindfulness
Measured using Mindful Attention Awareness Scale (1-6, where 6 is better outcome)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Apr 2024
- Primary completion24 May 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainful
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sarah Oliver, Gainful
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603038
- Sponsor's protocol ID
- Gainful
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Wellbeing and Focus with Daily Greens Supplementation
- ClinicalTrials.gov ID
- NCT06603038
- Acronym / sponsor ID
- Gainful
- Conditions
- Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- GainfulIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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.
This study aims to investigate whether daily consumption of Gainful Daily Performance Greens for four weeks contributes to improved scores of wellbeing and focus in healthy adults, as compared to a control group of non-supplement takers. The research question will be addressed by evaluating participants' responses using the World Health Organization's WHO-5 Wellbeing Index and the Mindful Attention Awareness Scale.
Detailed description
Purpose: The primary objective of this study is to assess the potential benefits of Gainful Daily Performance Greens on wellbeing and focus in healthy adults. The formulation of this supplement includes ingredients believed to support mental clarity and overall wellbeing. Understanding the impact of this product on subjective measures of wellbeing and focus will provide valuable insights into its potential benefits for a broader population.
Hypotheses: H0 (null hypothesis): There is no significant difference in wellbeing and focus scores between baseline and after four weeks of daily Gainful Daily Performance Greens consumption in healthy adults. H1 (alternate hypothesis): Daily consumption of Gainful Daily Performance Greens for four weeks results in improved scores of wellbeing and focus as measured by the WHO-5 Wellbeing Index and Mindful Attention Awareness Scale compared to baseline in healthy adults.
Goals and Objectives: The primary goal is to examine the potential positive effects of Gainful Daily Performance Greens on wellbeing and focus. Specific objectives include comparing pre- and post-supplementation scores using validated measures, identifying any changes in subjective experiences related to mental clarity and wellbeing, and exploring potential factors influencing individual responses.
Significance of Study: Understanding the impact of Gainful Daily Performance Greens on wellbeing and focus addresses the growing interest in functional foods and dietary supplements. If the study demonstrates positive effects, it may provide evidence for the inclusion of such supplements in promoting overall mental health and wellbeing in healthy adults.
Contribution to Field: This study contributes to the emerging field of nutritional interventions for overall wellbeing. By using established scales to measure wellbeing and focus, the research aims to provide valuable insights into the potential benefits of Gainful Daily Performance Greens, informing future research and dietary recommendations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Gainful Daily Performance GreensSupplementation with Daily Performance Greens daily for 28 days |
| Control | No intervention | –Control group, no supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not currently taking cognitive-enhancing supplements or medications
- Provide informed consent
- Have the ability to comply with the study protocol
Key exclusion criteria (1 listed)
- Known allergy to the ingredients of Daily Performance Greens
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 |
|---|---|---|
| Gainful Daily Performance GreensDaily supplementation for 28 days | Dietary supplement | Intervention |
Primary outcome
Perceived Wellbeing
Time frame: 28 days
Measured using WHO-5 Wellbeing Index Scale (0-5, where 5 is better outcome)
Mindfulness
Time frame: 28 days
Measured using Mindful Attention Awareness Scale (1-6, where 6 is better outcome)
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gainful Daily Performance Greens in people with Well-Being, Psychological, run by Gainful 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 3 inclusion and 1 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 19 Sep 2024. 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?
Perceived Wellbeing (time frame: 28 days). The study lists 2 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 19 Sep 2024.