Clinical trial NCT06387251: Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
Official title: A Decentralized Study to Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Health
Lead sponsor: Peryam & Kroll Research Corporation
Sponsor class: OTHER
Collaborators: name: Alticor Inc.
First posted: 2024-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Aged 20-65 years
3. Anyone willing to comply with study requirements
4. Anyone with no known allergies to the ingredients listed in the products
5. Generally healthy - do not live with any uncontrolled chronic disease - but looking to improve their general life-style and diet

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or attempting to conceive
2. Already follow a healthy plant-based diet and exercise regularly
3. Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
4. Individuals with a known history of severe diagnosed digestive disorders (e.g., Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease) or gastrointestinal-track surgeries
5. Planning to undergo an invasive medical procedure or GI surgery during the study period
6. Regular intake of medications that may interfere with the study or study product, including laxatives, sedatives, beta-blockers, anti-acids, etc.
7. Chronic smokers
8. Anyone with a history of substance abuse
9. Allergy to the products ingredients
10. Anyone with known severe allergic reactions that require an Epi-Pen
11. Anyone unwilling to follow the study protocol or unable to commit to the regiment for 28 days
12. Anyone currently participating or planning to participate other research study(s)
13. Regular consumption of probiotics, fiber, or digestive health supplements within 3 weeks of the study
14. People who participated in a weight loss or similar program within less than 3 months ago.

Primary outcomes:
measure: Bristol Stool Scale
timeFrame: Baseline, Day 16, Day 30
measure: Digestive symptom frequency questionnaire
timeFrame: Baseline, Day 16, Day 30
Secondary outcomes:
measure: Waist Circumference
timeFrame: Baseline and Day 30
measure: Improvements in sleep
timeFrame: Baseline, Day 16, Day 30
measure: Improvements in stress
timeFrame: Baseline, Day 16, Day 30
measure: Fitness Level
timeFrame: days 3-30
measure: Satiety Responsiveness and Hunger
timeFrame: Baseline, Day 16, Day 30
measure: Craving Intensity
timeFrame: Baseline, Day 16, Day 30
measure: Cognitive Abilities
timeFrame: Baseline, Day 16, Day 30
measure: Fatigue
timeFrame: Baseline, Day 16, Day 30
measure: Skin Appearance
timeFrame: Baseline and Day 30
measure: General Health
timeFrame: Baseline and Day 30
measure: Program Feedback
timeFrame: Day 30
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Wilkins Research
state: Tennessee
Study officials:
affiliation: Peryam & Kroll Research Corporation
name: George e Brown II
role: PRINCIPAL_INVESTIGATOR
References: