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

April 23, 2024 updated by: Peryam & Kroll Research Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Wilkins Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Protein Powder
Participants in Group A used the green powder supplement, probiotic supplement and protein Powder.
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.
Other: All-in-one Meal Powder
Participants in Group B used the green powder supplement, probiotic supplement and All-in-one Meal Powder.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bristol Stool Scale
Time Frame: Baseline, Day 16, Day 30
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
Time Frame: Baseline, Day 16, Day 30

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist Circumference
Time Frame: Baseline and Day 30

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
Improvements in sleep
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Improvements in stress
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Fitness Level
Time Frame: days 3-30

To examine the impact of the products and program on participants physical activity Endpoint: Fitness level

Fitness tracker measured daily steps
days 3-30
Satiety Responsiveness and Hunger
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Craving Intensity
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Cognitive Abilities
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Fatigue
Time Frame: Baseline, Day 16, Day 30

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
Baseline, Day 16, Day 30
Skin Appearance
Time Frame: Baseline and Day 30

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
Baseline and Day 30
General Health
Time Frame: Baseline and Day 30

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
Baseline and Day 30
Program Feedback
Time Frame: Day 30

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
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peryam & Kroll Research Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alticor Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George e Brown II, Peryam & Kroll Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-11-437-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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