Digestive System DiseaseNCT06283732
A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.
A study testing Greens powder in people with Digestive System Disease, run by Amway Corp at 1 site in United States.
Trial summary
The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Digestive System Disease
- What is being tested?
- Greens powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 15 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Aged 18-65 years.
- Willing to comply with study requirements.
- No known allergies to the ingredients listed in the product.
- Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
- Generally healthy - do not live with any uncontrolled chronic disease .
Who cannot join
- Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
- Known severe allergic reactions that require an Epi-Pen.
- Women who are pregnant, breastfeeding, or attempting to conceive.
- History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
- Unwillingness to follow the study protocol.
- Invasive medical procedure within the last three weeks or planning one during the study period.
Show all 10Show fewer
- History of substance abuse.
- Current participation or planning to participate in another research study.
- Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.
- Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) .
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.
- Conditions
- Digestive System Disease
- Being tested
- Greens powder
- Keywords
- Dietary Supplements, Digestive Health, Well-being, Energy Levels
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greens powderDietary supplement
Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Greens powder | Experimental | Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks. Receives: Dietary Supplement: Greens powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive Health Improvement
Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).
Measured: 14 days from the start of intervention
Secondary outcomes (1)
Quality of Life and Well-being Enhancement
Assess improvements in participants' quality of life, energy levels, satiety, and overall well-being through validated questionnaires.
Measured: 14 days from the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Nov 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amway Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283732
- Sponsor's protocol ID
- 20392
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.
- ClinicalTrials.gov ID
- NCT06283732
- Acronym / sponsor ID
- 20392
- Conditions
- Digestive System Disease
- Keywords
- Dietary Supplements, Digestive Health, Well-being, Energy Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Amway CorpIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 28 Feb 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 study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Greens powder | Experimental | Dietary Supplement: Greens powderParticipants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female.
- Aged 18-65 years.
- Willing to comply with study requirements.
- No known allergies to the ingredients listed in the product.
- Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
Key exclusion criteria (10 listed)
- Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
- Known severe allergic reactions that require an Epi-Pen.
- Women who are pregnant, breastfeeding, or attempting to conceive.
- History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
- Unwillingness to follow the study protocol.
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 |
|---|---|---|
| Greens powderParticipants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks. | Dietary supplement | Dietary Supplement: Greens powder |
Primary outcome
Digestive Health Improvement
Time frame: 14 days from the start of intervention
Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).
1 secondary outcome
Quality of Life and Well-being Enhancement
Time frame: 14 days from the start of intervention
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 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Digestive System Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greens powder in people with Digestive System Disease, run by Amway Corp 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 6 inclusion and 10 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 5 Mar 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?
Digestive Health Improvement (time frame: 14 days from the start of intervention). 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 5 Mar 2024.