A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI Health and related health outcomes.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,501
Participants will use their GI Product Placebo Control as directed for a period of 6 weeks.
Participants will use their GI Active Product 1 as directed for a period of 6 weeks.
Participants will use their GI Active Product 2 as directed for a period of 6 weeks.
Radicle Science Inc.
Del Mar, California, United States
Change in lower GI health
Difference between rates of change over time in lower GI collective score as assessed by a composite of PROMIS Gas and Bloating 13A , Constipation 9A, Diarrhea 6A, and Belly Pain 5A (scores 10-84; where the higher scores correspond to worse lower GI health)
Time frame: 7 weeks
Change in sleep
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance
Time frame: 7 weeks
Change in GI-related quality of life
Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Time frame: 7 weeks
Change in global health
Change in global health: Difference in rates of change over time in global score as assessed by PROMIS Global health (scale 9-45; where higher scores correspond to better global health).
Time frame: 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will use their GI Active Product 3 as directed for a period of 6 weeks.
Participants will use their GI Active Product 4 as directed for a period of 6 weeks.
Participants will use their GI Active Product 5 as directed for a period of 6 weeks.