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Completed

NCT Number: NCT06376695

Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

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Key information

Conditions

Abdominal Pain Digestion Digestive System Diseases GI Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
  • Resides in the United States
  • Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains
  • Has the opportunity for at least 20% improvement in their primary health outcome
  • Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion criteria

  • Report being pregnant, trying to become pregnant, or breastfeeding
  • Unable to provide a valid US shipping address and mobile phone number
  • Reports current enrollment in another clinical trial
  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
  • Unable to read and understand English
  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
  • Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
  • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study product
  • Lack of reliable daily access to the internet

Treatment and study plan

Radicle GI Health Placebo Control Form 1

Dietary Supplement

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 1.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control Form 2

Dietary Supplement

Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 2.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control Form 3

Dietary Supplement

Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 3.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control Form 4

Dietary Supplement

Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 4.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 4.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control Form 5

Dietary Supplement

Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 5.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 5.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control Form 7

Dietary Supplement

Participants will use their Placebo Control Form 7 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 7.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 7.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control 7.2

Dietary Supplement

Participants will use their Placebo Control 7.2 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 7.2.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 7.2.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control 7.3.0

Dietary Supplement

Participants will use their Placebo Control 7.3 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 7.3.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 7.3.1 as directed for a period of 6 weeks.

Radicle GI Health Placebo Control 7.4.0

Dietary Supplement

Participants will use their Placebo Control 7.4 as directed for a period of 6 weeks.

Radicle GI Health Active Study Product 7.4.1 Usage

Dietary Supplement

Participants will use their Radicle GI Health Active Study Product 7.4.1 as directed for a period of 6 weeks.

Primary outcomes

  1. Change in GI (Gastrointestinal) Health (1)

    Time frame: 6 weeks

    Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)

  2. Change in GI (Gastrointestinal) Health (2)

    Time frame: 6 weeks

    Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)

  3. Change in GI (Gastrointestinal) Health (3)

    Time frame: 6 weeks

    Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation)

  4. Change in GI (Gastrointestinal) Health (4)

    Time frame: 6 weeks

    Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea)

  5. Change in GI (Gastrointestinal) Health (5)

    Time frame: 6 weeks

    Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)

  6. Change in GI (Gastrointestinal) Health (6)

    Time frame: 6 weeks

    Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)

Secondary outcomes

  1. Change in feelings of anxiety

    Time frame: 6 weeks

    Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

  2. Change in GI-related Quality of Life (QOL)

    Time frame: 6 weeks

    Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)

  3. Change in mood (emotional distress-depression)

    Time frame: 6 weeks

    Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)

  4. Minimal clinically important difference (MCID) in GI Health (1)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)

  5. Minimal clinically important difference (MCID) in GI Health (2)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)

  6. Minimal clinically important difference (MCID) in GI Health (3)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation)

  7. Minimal clinically important difference (MCID) in GI Health (4)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea)

  8. Minimal clinically important difference (MCID) in GI Health (5)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)

  9. Minimal clinically important difference (MCID) in GI Health (6)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)

  10. Minimal clinically important difference (MCID) in feelings of anxiety

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

  11. Minimal clinically important difference (MCID) in GI-related QOL

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)

  12. Minimal clinically important difference (MCID) in mood (emotional distress-depression)

    Time frame: 6 weeks

    Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)

Other outcomes

  1. Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

    Time frame: 6 weeks

    Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Test are optional. Unit of measure will vary based on test selected

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

Radicle GI Health™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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