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

NCT06387251 | Completed

• 1 other identifier: 2023-11-437-0003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Health

Outcome Measures

Primary Outcomes (2)

• 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

• 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. 1 day per month 2. 2 to 3 days per month 3. 1 day per week 4. More than 1 day per week 5. Every day

  Baseline, Day 16, Day 30

Secondary Outcomes (11)

• Waist Circumference

  Baseline and Day 30

• Improvements in sleep

  Baseline, Day 16, Day 30

• Improvements in stress

  Baseline, Day 16, Day 30

• Fitness Level

  days 3-30

• Satiety Responsiveness and Hunger

  Baseline, Day 16, Day 30

Study Arms (2)

Protein Powder

OTHER

Participants in Group A used the green powder supplement, probiotic supplement and protein Powder.

Other: 30 day wellness program

All-in-one Meal Powder

OTHER

Participants in Group B used the green powder supplement, probiotic supplement and All-in-one Meal Powder.

Other: 30 day wellness program

Interventions

30 day wellness program OTHER

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.

All-in-one Meal Powder; Protein Powder

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who are pregnant, breastfeeding, or attempting to conceive
• Already follow a healthy plant-based diet and exercise regularly
• Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
• 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
• Planning to undergo an invasive medical procedure or GI surgery during the study period
• Regular intake of medications that may interfere with the study or study product, including laxatives, sedatives, beta-blockers, anti-acids, etc.
• Chronic smokers
• Anyone with a history of substance abuse
• Allergy to the products ingredients
• Anyone with known severe allergic reactions that require an Epi-Pen
• Anyone unwilling to follow the study protocol or unable to commit to the regiment for 28 days
• Anyone currently participating or planning to participate other research study(s)
• Regular consumption of probiotics, fiber, or digestive health supplements within 3 weeks of the study
• People who participated in a weight loss or similar program within less than 3 months ago.

Sponsors & Collaborators

• Peryam & Kroll Research Corporation: lead
• Alticor Inc.: collaborator

Study Sites (1)

Wilkins Research

Chattanooga, Tennessee, 37421, United States

Location

MeSH Terms

Interventions

Health Promotion

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• George e Brown II

  Peryam & Kroll Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 29, 2024
• Study Start: January 29, 2024
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)