- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603038
Perceived Wellbeing and Focus with Daily Greens Supplementation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10001
- Gainful
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not currently taking cognitive-enhancing supplements or medications
- Provide informed consent
- Have the ability to comply with the study protocol
Exclusion Criteria:
- Known allergy to the ingredients of Daily Performance Greens
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Supplementation with Daily Performance Greens daily for 28 days
|
Daily supplementation for 28 days
|
|
No Intervention: Control
Control group, no supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Wellbeing
Time Frame: 28 days
|
Measured using WHO-5 Wellbeing Index Scale (0-5, where 5 is better outcome)
|
28 days
|
|
Mindfulness
Time Frame: 28 days
|
Measured using Mindful Attention Awareness Scale (1-6, where 6 is better outcome)
|
28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Gainful
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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