Healthy SubjectsNCT06680219
Evaluation of the the Efficacy of a Digestive Health Supplement in Healthy Subjects
A study testing Active comparator in people with Healthy Subjects, run by Pharmanex at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate the efficacy of a digestive health supplement via waist circumference measurements, daily bowel habit and symptom logs, and self-perception questionnaires (SPQ) over 4 weeks. To test for the following claims: Reduction of bloating after only one use. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2024to 31 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities.
- Subject routinely experiences gastrointestinal discomfort, specifically bloating.
- Subject has signed a written Informed Consent.
- Willing to use the test article as instructed following the directions for usage provided by the sponsor.
- Willing to attend study visits 1 and 3 having fasted for 8 hours (only water allowed).
- Willing to consume a test meal in conjunction with the supplement on study visits 1 and 3.
Show all 9Show fewer
- Willing to record daily logs of their bowel habits and abdominal discomfort.
- Willing to attend all study visits.
- Photography subjects: subjects undergoing clinical photography of the abdomen area are willing to wear the same clothing to visits 1 and 3 (or at least the same colour clothing).
Who cannot join
- Subject is pregnant, nursing, or planning to become pregnant.
- Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
- Known allergies or hypersensitivity to dietary supplements, similar materials, or their ingredients including, but not limited to, hazelnuts, peanuts and pomegranates (family Lythraceae).
- Subject has allergies or sensitivity (other than bloating/indigestion issues/GI discomfort) to the ingredients of the test meal.
- Insulin dependent diabetes.
- Subjects with history of any gastrointestinal surgery, gastrointestinal illness which in the opinion of the Investigator would affect the digestive and absorption processes of the body (i.e., Gastric bypass, Gastroenteritis, Irritable Bowel Syndrome, Celiac Disease).
Show all 14Show fewer
- Medical condition that may affect study data or subject safety which in the opinion of the Investigator would compromise the safety of the subject or study results.
- History of poor cooperation, non-compliance, or unreliability.
- Investigator deems the subject an unsuitable candidate for the study.
- Subject is currently participating in another clinical trial involving dietary supplements or similar materials.
- Subject uses any prescription or over the counter (OTC) medication, vitamins, herbal products, antacids, mineral supplements and dietary supplements that target digestive issues and bloating within 4 weeks prior to the study start and through the end of study.
- Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study Visit.
- Subjects being treated with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazole's, fluoroquinolones, calcium channel blockers, proton pump inhibitors, or H2-receptor antagonists, etc., within 30 days prior to screening or through the end of study.
- Subjects with difficulty fasting or consuming standard meals or snacks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Double Blind, Placebo Controlled, Randomised Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of a Digestive Health Supplement
The objective of this study is to evaluate the efficacy of a digestive health supplement via waist circumference measurements, daily bowel habit and symptom logs, and self-perception questionnaires (SPQ) over 4 weeks.
To test for the following claims:
Read more
- Reduction of bloating after only one use.
- SPQ claims - to be determined by the sponsor.
- Improvement to a range of upper and lower gastrointestinal symptoms (heartburn, belching, bloating, nausea, vomiting, flatulence, intestinal cramps, urge to defecate, loose stool, and diarrhea)
- Clinically proven formulation
- Supports relief of bloating discomfort
- Supports quick and effective reduction in bloating related to food intake
- Study shows X% severity reduction in abdominal bloating
- Helps support a reduction in days experiencing bloating
- Supports a reduction in abdominal discomfort
- X% of participants reported a reduction in bloating during the study
- Supports a reduction in waist circumference, related to bloating
Please note that it is the responsibility of the sponsor to determine the testing and study designs required for submission to entities such as the Home Shopping Network, QVC, etc.
Read the detailed description
Title: A single centre, double blind, placebo controlled, randomised clinical study design in healthy subjects to evaluate the efficacy of a digestive health supplement.
Study design: Single centre, placebo controlled, randomised 4-week home use study.
Test article: 1. ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) 2. PLACEBO - Crystal Light Raspberry Lemonade
Duration of study: Approximately 4 weeks
Number of subjects: Enough subjects will be recruited onto the study to finish with 50 subjects overall across two (2) study groups:
Group 1: at least 20 subjects in the placebo group.
Group 2: at least 30 subjects in the active test article group.
Types of subjects: Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities. Subjects must routinely experience gastrointestinal discomfort, specifically bloating.
Observations: Assessments for the randomised home use 4-week study consist of the following:
- Daily bowel habits log.
- Daily abdominal discomfort logs covering upper and lower gastrointestinal (GI) issues.
- Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline, week 2, and week 4.
- Self-perception questionnaire for bloating at the 1st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
- Waist circumference measurements at the 1 st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
- Digital Photography of 20 subjects (10 from Group 1, 10 from Group 2) at the 1st study visit (baseline and after 1 hour), and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
- Conditions
- Healthy Subjects
- Being tested
- Placebo, Active comparator
- Keywords
- Nu Biome, abdominal discomfort logs, bloating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Crystal Light Raspberry Lemonade: Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water).
Active comparatorDietary supplement
ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931): Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily.
(8-12 oz of water is approximately 236-354 mL of water).
| Study group | Role | What they receive |
|---|---|---|
| Placebo controlled, randomised 4-week home use study | Placebo comparator | The sample is Crystal Light Raspberry Lemonade
Placebo sample Usage instructions for all groups:
2. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water). Receives: Dietary Supplement: Placebo |
| Active comparator for randomised 4-week home use study | Active comparator | ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931)
Active sample Usage instructions for all groups:
1. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water). Receives: Dietary Supplement: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily bowel habits log
Subjects in both arms will be asked to record their daily bowel habits in a diary using Bristol stool chart as a reference.
Measured: 30 days
Daily abdominal discomfort assessment
Daily abdominal discomfort assessment will be recorded by subjects in a diary using Bristol Stool Chart as a reference on a scale of 0 to 10, with 0 (no discomfort) to 10 (worst discomfort).
Measured: 30 days
Digestion-associated Quality of Life Questionnaire (DQLQ) assessment
Digestion-associated Quality of Life Questionnaire (DQLQ) will be assessed on a scale of 0% to 100% at baseline, week 2, and week 4, with 0% indicating no effect (never) on digestion-associated quality of life to 90%-100% (always effecting digestion-associated Quality of Life)
Measured: 30 days
Self-perception questionnaire for assessment of bloating
Assessment of bloating using a self-perception questionnaire on a scale of None (no bloating) to very severe (severe bloating) will be conducted at the 1st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start21 Feb 2024
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barrie Drewitt, Principal investigator, PCR CorpJamie Jarvis, Principal investigator, PCR Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680219
- Sponsor's protocol ID
- RIGSUP2C
- Other IDs
- RIGSUP2C
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2024
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Double Blind, Placebo Controlled, Randomised Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of a Digestive Health Supplement
- ClinicalTrials.gov ID
- NCT06680219
- Acronym / sponsor ID
- RIGSUP2C
- Conditions
- Healthy Subjects
- Keywords
- Nu Biome, abdominal discomfort logs, bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 8 Nov 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 objective of this study is to evaluate the efficacy of a digestive health supplement via waist circumference measurements, daily bowel habit and symptom logs, and self-perception questionnaires (SPQ) over 4 weeks.
To test for the following claims:
- Reduction of bloating after only one use.
- SPQ claims - to be determined by the sponsor.
- Improvement to a range of upper and lower gastrointestinal symptoms (heartburn, belching, bloating, nausea, vomiting, flatulence, intestinal cramps, urge to defecate, loose stool, and diarrhea)
- Clinically proven formulation
- Supports relief of bloating discomfort
- Supports quick and effective reduction in bloating related to food intake
- Study shows X% severity reduction in abdominal bloating
- Helps support a reduction in days experiencing bloating
- Supports a reduction in abdominal discomfort
- X% of participants reported a reduction in bloating during the study
- Supports a reduction in waist circumference, related to bloating
Please note that it is the responsibility of the sponsor to determine the testing and study designs required for submission to entities such as the Home Shopping Network, QVC, etc.
Detailed description
Title: A single centre, double blind, placebo controlled, randomised clinical study design in healthy subjects to evaluate the efficacy of a digestive health supplement.
Study design: Single centre, placebo controlled, randomised 4-week home use study.
Test article: 1. ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) 2. PLACEBO - Crystal Light Raspberry Lemonade
Duration of study: Approximately 4 weeks
Number of subjects: Enough subjects will be recruited onto the study to finish with 50 subjects overall across two (2) study groups:
Group 1: at least 20 subjects in the placebo group.
Group 2: at least 30 subjects in the active test article group.
Types of subjects: Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities. Subjects must routinely experience gastrointestinal discomfort, specifically bloating.
Observations: Assessments for the randomised home use 4-week study consist of the following:
- Daily bowel habits log.
- Daily abdominal discomfort logs covering upper and lower gastrointestinal (GI) issues.
- Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline, week 2, and week 4.
- Self-perception questionnaire for bloating at the 1st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
- Waist circumference measurements at the 1 st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
- Digital Photography of 20 subjects (10 from Group 1, 10 from Group 2) at the 1st study visit (baseline and after 1 hour), and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo controlled, randomised 4-week home use study | Placebo comparator | Dietary Supplement: PlaceboThe sample is Crystal Light Raspberry Lemonade Placebo sample Usage instructions for all groups: 2. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water). |
| Active comparator for randomised 4-week home use study | Active comparator | Dietary Supplement: Active comparatorACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) Active sample Usage instructions for all groups: 1. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities.
- Subject routinely experiences gastrointestinal discomfort, specifically bloating.
- Subject has signed a written Informed Consent.
- Willing to use the test article as instructed following the directions for usage provided by the sponsor.
- Willing to attend study visits 1 and 3 having fasted for 8 hours (only water allowed).
Key exclusion criteria (14 listed)
- Subject is pregnant, nursing, or planning to become pregnant.
- Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
- Known allergies or hypersensitivity to dietary supplements, similar materials, or their ingredients including, but not limited to, hazelnuts, peanuts and pomegranates (family Lythraceae).
- Subject has allergies or sensitivity (other than bloating/indigestion issues/GI discomfort) to the ingredients of the test meal.
- Insulin dependent diabetes.
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 |
|---|---|---|
| PlaceboCrystal Light Raspberry Lemonade: Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water). | Dietary supplement | Placebo controlled, randomised 4-week home use study |
| Active comparatorACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931): Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily. (8-12 oz of water is approximately 236-354 mL of water). | Dietary supplement | Active comparator for randomised 4-week home use study |
Primary outcome
Daily bowel habits log
Time frame: 30 days
Subjects in both arms will be asked to record their daily bowel habits in a diary using Bristol stool chart as a reference.
Daily abdominal discomfort assessment
Time frame: 30 days
Daily abdominal discomfort assessment will be recorded by subjects in a diary using Bristol Stool Chart as a reference on a scale of 0 to 10, with 0 (no discomfort) to 10 (worst discomfort).
Digestion-associated Quality of Life Questionnaire (DQLQ) assessment
Time frame: 30 days
Digestion-associated Quality of Life Questionnaire (DQLQ) will be assessed on a scale of 0% to 100% at baseline, week 2, and week 4, with 0% indicating no effect (never) on digestion-associated quality of life to 90%-100% (always effecting digestion-associated Quality of Life)
Self-perception questionnaire for assessment of bloating
Time frame: 30 days
Assessment of bloating using a self-perception questionnaire on a scale of None (no bloating) to very severe (severe bloating) will be conducted at the 1st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).
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 8 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
Barrie Drewitt principal investigator
PCR Corp
Jamie Jarvis principal investigator
PCR Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator in people with Healthy Subjects, run by Pharmanex at 1 site in United Kingdom.
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 9 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 8 Nov 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Daily bowel habits log (time frame: 30 days). The study lists 4 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 8 Nov 2024.