protocolSection identificationModule nctId: NCT06387251, orgStudyIdInfo id: 2023-11-437-0003, briefTitle: Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peryam & Kroll Research Corporation, class: OTHER, collaborators name: Alticor Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Digestive Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: 30 day wellness program, outcomesModule primaryOutcomes measure: Bristol Stool Scale, primaryOutcomes measure: Digestive symptom frequency questionnaire, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Improvements in sleep, secondaryOutcomes measure: Improvements in stress, secondaryOutcomes measure: Fitness Level, secondaryOutcomes measure: Satiety Responsiveness and Hunger, secondaryOutcomes measure: Craving Intensity, secondaryOutcomes measure: Cognitive Abilities, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Skin Appearance, secondaryOutcomes measure: General Health, secondaryOutcomes measure: Program Feedback, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wilkins Research, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, geoPoint lat: 35.04563, lon: -85.30968, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-11, uploadDate: 2024-03-07T13:19, filename: ICF_000.pdf, size: 144142, hasResults: False