Digestive HealthNCT06387251
Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
A study testing 30 day wellness program in people with Digestive Health, run by Peryam & Kroll Research Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health
- What is being tested?
- 30 day wellness program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Digestive Health
- Being tested
- 30 day wellness program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 day wellness programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Protein Powder | Other | Participants in Group A used the green powder supplement, probiotic supplement and protein Powder. Receives: 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. Receives: Other: 30 day wellness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 day per month
- 2 to 3 days per month
- 1 day per week
- More than 1 day per week
- Every day
Measured: Baseline, Day 16, Day 30
Secondary outcomes (11)
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
Measured: 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
- very good
- good
- fair
- poor
- very poor
Measured: 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
- very good
- good
- fair
- poor
- very poor
Measured: 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
Measured: 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
- Strongly disagree
- Disagree
- Neither agree or disagree
- Agree
- Strongly agree
Measured: 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
- none at all
- significantly less than usual
- slightly less than usual
- as usual
- slightly more than usual
- significantly more than usual
- more than ever
Measured: 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
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
Measured: 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
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
Measured: 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
- = very dissatisfied
- = somewhat dissatisfied
- = neither satisfied nor dissatisfied
- = somewhat satisfied
- = very satisfied
Measured: 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
- - Excellent
- - Very good
- - Good
- - Fair
- - Poor
1 = Definitely true 2 = Mostly true 3 = Don't know 4 = Mostly false 5 = Definitely False
Measured: 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
- 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
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start29 Jan 2024
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peryam & Kroll Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Alticor Inc.
- Responsible party
- Sponsor
- Investigators
- George e Brown II, Principal investigator, Peryam & Kroll Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387251
- Sponsor's protocol ID
- 2023-11-437-0003
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Study to Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being
- ClinicalTrials.gov ID
- NCT06387251
- Acronym / sponsor ID
- 2023-11-437-0003
- Conditions
- Digestive Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peryam & Kroll Research CorporationUniversity, hospital or other
- Collaborators
- Alticor Inc.
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein Powder | Other | Other: 30 day wellness programParticipants in Group A used the green powder supplement, probiotic supplement and protein Powder. |
| All-in-one Meal Powder | Other | Other: 30 day wellness programParticipants in Group B used the green powder supplement, probiotic supplement and All-in-one Meal Powder. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 day wellness program30 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, Protein Powder |
Primary outcome
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
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
11 secondary outcomes
Waist Circumference
Time frame: Baseline and Day 30
Improvements in sleep
Time frame: Baseline, Day 16, Day 30
Improvements in stress
Time frame: Baseline, Day 16, Day 30
Fitness Level
Time frame: days 3-30
Satiety Responsiveness and Hunger
Time frame: Baseline, Day 16, Day 30
Craving Intensity
Time frame: Baseline, Day 16, Day 30
Cognitive Abilities
Time frame: Baseline, Day 16, Day 30
Fatigue
Time frame: Baseline, Day 16, Day 30
Skin Appearance
Time frame: Baseline and Day 30
General Health
Time frame: Baseline and Day 30
Program Feedback
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George e Brown II principal investigator
Peryam & Kroll Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 day wellness program in people with Digestive Health, run by Peryam & Kroll Research Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol Stool Scale (time frame: Baseline, Day 16, Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.