Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being

Digestive Health Clinical Trial

Official title:

A Decentralized Study to Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06387251
• Other study ID #: 2023-11-437-0003
• Status: Completed
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Peryam & Kroll Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive Health

Intervention

Other:
• 30 day wellness program
30 days and will evaluate the effects of sponsor-designed 30-day wellness program consisting of 3 supplement and functional food products, recommended diet, physical activity, hydration and mindfulness activities.

Locations

Country	Name	City	State
United States	Wilkins Research	Chattanooga	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Peryam & Kroll Research Corporation	Alticor Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bristol Stool Scale	To examine the effectiveness the products and program regiment on digestive health outcomes Endpoint: Reduction in digestive symptoms Type 1 - Separate hard lumps Type 2 - lumpy and sausage like Type 3 - A sausage shape with cracks in the surface Type 4 - like a smooth, soft sausage or snake Type 5 - Soft blobs with clear cut edges Type 6 - Mushy consistency with ragged edges Type 7 - Liquid consistency with no solid pieces N/A	Baseline, Day 16, Day 30
Primary	Digestive symptom frequency questionnaire	To examine the effectiveness the products and program regiment on digestive health outcomes Endpoint: Reduction in digestive symptoms 0= never; 1 day per month; 2 to 3 days per month; 1 day per week; More than 1 day per week; Every day	Baseline, Day 16, Day 30
Secondary	Waist Circumference	To examine the impact of the products and Program on Weight Loss and Abdominal Fat Endpoint: Weight loss, reduction in Waist Circumference; Self-measured by participants	Baseline and Day 30
Secondary	Improvements in sleep	To examine the impact of the products and program sleep Endpoint: Sleep Quality; Fitness tracker measured sleep score PROMIS Sleep disturbances 4a; very good; good; fair; poor; very poor	Baseline, Day 16, Day 30
Secondary	Improvements in stress	To examine the impact of the products and program stress Endpoint: Stress Quality; Fitness tracker measured stress score PROMIS Sleep disturbances 4a; very good; good; fair; poor; very poor	Baseline, Day 16, Day 30
Secondary	Fitness Level	To examine the impact of the products and program on participants physical activity Endpoint: Fitness level; Fitness tracker measured daily steps	days 3-30
Secondary	Satiety Responsiveness and Hunger	To examine the impact of the products and program on satiety and hunger Endpoint: Satiety, hunger; Satiety Responsiveness and Hunger Subscale; Strongly disagree; Disagree; Neither agree or disagree; Agree; Strongly agree	Baseline, Day 16, Day 30
Secondary	Craving Intensity	To examine the impact of the products and program on sweet and rich food cravings Endpoint: sweet or rich food cravings; Intensity of Cravings subscale; none at all; significantly less than usual; slightly less than usual; as usual; slightly more than usual; significantly more than usual; more than ever	Baseline, Day 16, Day 30
Secondary	Cognitive Abilities	To examine the impact of the products and program on physical and psychological fatigue Endpoint: Cognitive Abilities; PROMIS Cognitive Abilities 6a; Not at all; A little bit; Somewhat; Quite a bit; Very much	Baseline, Day 16, Day 30
Secondary	Fatigue	To examine the impact of the products and program on physical and psychological fatigue Endpoint: Fatigue/Energy; PROMIS Fatigue 6a; Not at all; A little bit; Somewhat; Quite a bit; Very much	Baseline, Day 16, Day 30
Secondary	Skin Appearance	To examine the impact of the products and program on general skin appearance Endpoint: General Health; Skin Appearance Satisfaction; = very dissatisfied; = somewhat dissatisfied; = neither satisfied nor dissatisfied; = somewhat satisfied; = very satisfied	Baseline and Day 30
Secondary	General Health	To examine the impact of the products and program on general health Endpoint: General Health; SF-36 Questionnaire - General Health sub Scale; - Excellent; - Very good; - Good; - Fair; - Poor; 1 = Definitely true 2 = Mostly true 3 = Don't know 4 = Mostly false 5 = Definitely False	Baseline and Day 30
Secondary	Program Feedback	To collect Participants feedback on the products and Program Endpoint: Likeness & Suitability of such regiment for broader use; Which programs.......enjoyment? Diet plan Staying active Exercise Hydration Mindfulness activities Products None of the above; Which products......enjoyment? Green Powder Supplement Probiotic Supplement Protein Powder All in one Meal Powder None of the above; RATE HOW LIKELY WOULD YOU; Extremely Unlikely; Highly Unlikely; Very Unlikely; Unlikely; Neutral; Somewhat Likely; Likely; Very likely; Extremely likely; RATE HOW LIKELY WOULD YOU; Very Unlikely; Unlikely; Don't know; Likely; Very likely	Day 30