An interventional study of Placebo Control Form 1 and Calm Active Study Product 1.1 Usage in Anxiety and Stress, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety 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) endorse a desire for less feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) 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 over 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.
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 502 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Radicle Science is the lead sponsor of 64 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Calm Product Form 1 - control
Dietary Supplement: Placebo Control Form 1
Calm Product Form 1 - active product 1
Dietary Supplement: Calm Active Study Product 1.1 Usage
Calm Product 6.1 - control
Dietary Supplement: Placebo Control 6.1
Calm Product 6.1 - active product 1
Dietary Supplement: Calm Active Study Product 6.1 Usage
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control 6.1 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 6.1 as directed for a period of 6 weeks.
Change in feelings of anxiety
Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
Time frame: 6 weeks
Change in stress
Mean difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)
Time frame: 6 weeks
Change in sleep
Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)
Time frame: 6 weeks
Change in mood (emotional distress)
Mean difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of achieving a MCID in sleep disturbance, as measured by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in stress
Likelihood of experiencing minimal clinically important difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in mood (emotional distress)
Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1)
Mean difference in saliva concentration as assessed by saliva-based IgG (Immunoglobulin) biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2)
Mean difference in saliva concentration as assessed by saliva-based cytokines (Interleukin 1 beta, Interleukin 8, Tumor necrosis factor-alpha, and Interleukin 6) biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3)
Mean difference in saliva concentration as assessed by saliva-based dehydroepiandrosterone sulfate (DHEA-S) biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (4)
Mean difference in saliva concentration as assessed by saliva-based estradiol biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (5)
Mean difference in saliva concentration as assessed by saliva-based progesterone biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (6)
Mean difference in saliva concentration as assessed by saliva-based testosterone biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (7)
Mean difference in saliva concentration as assessed by saliva-based cortisol biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (8)
Mean difference in saliva concentration as assessed by saliva-based melatonin biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in saliva concentration of at-home (direct-to-consumer) specimen assay (9)
Mean difference in saliva concentration as assessed by saliva-based C-Reactive Protein (CRP) biomarker. (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (1)
Mean difference in blood concentration as assessed by blood-based cortisol biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (2)
Mean difference in blood concentration as assessed by blood-based homocysteine biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (3)
Mean difference in blood concentration as assessed by blood-based ferritin biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (4)
Mean difference in blood concentration as assessed by blood-based thyroid stimulating hormone (TSH) biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (5)
Mean difference in blood concentration as assessed by blood-based hemoglobin A1C (HbA1c) biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (6)
Mean difference in blood concentration as assessed by blood-based insulin biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (7)
Mean difference in blood concentration as assessed by blood-based vitamin D biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (8)
Mean difference in blood concentration as assessed by blood-based dehydroepiandrosterone sulfate (DHEA-S) biomarker (1 drop). (Optional; among consented male participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (9)
Mean difference in blood concentration as assessed by blood-based testosterone biomarker (1 drop) (Optional; among consented male participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (10)
Mean difference in blood concentration as assessed by blood-based estradiol biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (11)
Mean difference in blood concentration as assessed by blood-based follicle-stimulating hormone (FSH) biomarker (1 drop). (Optional; among consented female participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (12)
Mean difference in blood concentration as assessed by blood-based total cholesterol (high-density lipoproteins (HDL) and low-density lipoproteins (LDL)) biomarker (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in blood concentration of at-home (direct-to-consumer) specimen assay (13)
Mean difference in blood concentration as assessed by blood-based triglycerides (apolipoprotein A1 (ApoA1) and apolipoprotein B (ApoB)) (1 drop). (Optional; among consented participants only).
Time frame: 6 weeks
Change in stool concentration of at-home (direct-to-consumer) specimen assay
Mean difference in stool concentration as assessed by a stool sample (microbial diversity) (Optional; among consented participants only).
Time frame: 6 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radicle Science