Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
Study NCT ID:
NCT06387251
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
Sponsor:
Peryam & Kroll Research Corporation
Organization:
Study Overview
Official Title:
A Decentralized Study to Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being.
Detailed Description:
This is a two-groups, virtual study where participants consume the green powder, probiotic and protein or meal replacement products and follow diet, hydration, physical activity and mindfulness activity regiment daily and provide feedback through the fitness tracker data, various questionnaires and measurement of basic biometrics over 30 days. The two-group design was chosen to obtain the data on the effects of the greens, probiotic products and protein vs a meal replacement food on a diverse group of participants. A virtual study ensures a broader reach and caters to the current trend of decentralized studies, which are more flexible and participant-centric. The choice of collecting daily fitness tracker data, spaced questionnaires and biometrics is to capture both immediate and cumulative effects of the products and the life-style regimen on the participants' health. A placebo has not been incorporated as it is not feasible to design a true placebo products that would taste and look indistinguishable from the intervention and placebo to the life-style regiment with a diet, physical activity, hydration, mindfulness activities are not feasible. The participants will be blinded to the sponsor name, brand name, and the exact products name.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: