A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
2,180
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
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)
Time frame: 6 weeks
Change in abdominal pain
Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
Time frame: 6 weeks
Change in gas/bloating
Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
Time frame: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in GI-related QOL
Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in abdominal pain
Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Time frame: 6 weeks
Minimal clinically important difference (MCID) in gas/bloating
Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
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Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
Time frame: 6 weeks