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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
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.
Wilkins Research
Chattanooga, Tennessee, United States
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
Time frame: 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
Time frame: Baseline, Day 16, Day 30
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
Time frame: Baseline and Day 30
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 1. very good 2. good 3. fair 4. poor 5. very poor
Time frame: Baseline, Day 16, Day 30
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 1. very good 2. good 3. fair 4. poor 5. very poor
Time frame: Baseline, Day 16, Day 30
Fitness Level
To examine the impact of the products and program on participants physical activity Endpoint: Fitness level Fitness tracker measured daily steps
Time frame: days 3-30
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 1. Strongly disagree 2. Disagree 3. Neither agree or disagree 4. Agree 5. Strongly agree
Time frame: Baseline, Day 16, Day 30
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 1. none at all 2. significantly less than usual 3. slightly less than usual 4. as usual 5. slightly more than usual 6. significantly more than usual 7. more than ever
Time frame: Baseline, Day 16, Day 30
Cognitive Abilities
To examine the impact of the products and program on physical and psychological fatigue Endpoint: Cognitive Abilities PROMIS Cognitive Abilities 6a 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
Time frame: Baseline, Day 16, Day 30
Fatigue
To examine the impact of the products and program on physical and psychological fatigue Endpoint: Fatigue/Energy PROMIS Fatigue 6a 1. Not at all 2. A little bit 3. Somewhat 4. Quite a bit 5. Very much
Time frame: Baseline, Day 16, Day 30
Skin Appearance
To examine the impact of the products and program on general skin appearance Endpoint: General Health Skin Appearance Satisfaction 1. = very dissatisfied 2. = somewhat dissatisfied 3. = neither satisfied nor dissatisfied 4. = somewhat satisfied 5. = very satisfied
Time frame: Baseline and Day 30
General Health
To examine the impact of the products and program on general health Endpoint: General Health SF-36 Questionnaire - General Health sub Scale 1. \- Excellent 2. \- Very good 3. \- Good 4. \- Fair 5. \- Poor 1 = Definitely true 2 = Mostly true 3 = Don't know 4 = Mostly false 5 = Definitely False
Time frame: Baseline and Day 30
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 1. Extremely Unlikely 2. Highly Unlikely 3. Very Unlikely 4. Unlikely 5. Neutral 6. Somewhat Likely 7. Likely 8. Very likely 9. Extremely likely RATE HOW LIKELY WOULD YOU 1. Very Unlikely 2. Unlikely 3. Don't know 4. Likely 5. Very likely
Time frame: Day 30
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