Trial Outcomes & Findings for Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens (NCT NCT03978117)
NCT ID: NCT03978117
Last Updated: 2025-11-21
Results Overview
Carcinogen detoxification metabolites in urine. Biomarkers to be analyzed: 2-cyanoethyl mercapturic acid (CEMA), 3-hydroxypropyl mercapturic acid (HPMA1), 2-hydroxypropyl mercapturic acid (HPMA2), phenyl mercapturic acid (SPMA), 3-hydroxy-1-methylpropyl mercapturic acid (HMPMA1), 3-hydroxy-2-methylpropyl mercapturic acid (HMPMA2), and 3-hydroxy-3-methylpropyl mercapturic acid (HMPMA3),
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
2 Months
Results posted on
2025-11-21
Participant Flow
300 participants randomized to treatment arms. 188 analyzed for study objectives.
Participant milestones
| Measure |
Freeze Dried Watercress Preparation Then Placebo
Participants were randomly assigned to the watercress then placebo arm. During the treatment phase, participants consumed the watercress beverage 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the placebo beverage for 14 days. The placebo was consumed in the same pattern 3 times per day around meals as the watercress beverage.
|
Placebo Then Freeze Dried Watercress Preparation
Participants were randomly assigned to the placebo then watercress arm. During the treatment phase, participants consumed the placebo beverage, 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the watercress beverage for 14 days. The watercress beverage was consumed in the same pattern 3 times per day around meals as the placebo beverage.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
145
|
|
Overall Study
COMPLETED
|
125
|
115
|
|
Overall Study
NOT COMPLETED
|
30
|
30
|
Reasons for withdrawal
| Measure |
Freeze Dried Watercress Preparation Then Placebo
Participants were randomly assigned to the watercress then placebo arm. During the treatment phase, participants consumed the watercress beverage 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the placebo beverage for 14 days. The placebo was consumed in the same pattern 3 times per day around meals as the watercress beverage.
|
Placebo Then Freeze Dried Watercress Preparation
Participants were randomly assigned to the placebo then watercress arm. During the treatment phase, participants consumed the placebo beverage, 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the watercress beverage for 14 days. The watercress beverage was consumed in the same pattern 3 times per day around meals as the placebo beverage.
|
|---|---|---|
|
Overall Study
self- withdrawal or PI withdrawal
|
26
|
26
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
Baseline characteristics by cohort
| Measure |
Freeze Dried Watercress Preparation Then Placebo
n=108 Participants
Participants were randomly assigned to the watercress then placebo arm. During the treatment phase, participants consumed the watercress beverage 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the placebo beverage for 14 days. The placebo was consumed in the same pattern 3 times per day around meals as the watercress beverage.
|
Placebo Then Freeze Dried Watercress Preparation
n=80 Participants
Participants were randomly assigned to the placebo then watercress arm. During the treatment phase, participants consumed the placebo beverage, 3 times per day (around the time of breakfast, lunch and dinner) for 14 days. Participants had a 4-week washout period before switching to the watercress beverage for 14 days. The watercress beverage was consumed in the same pattern 3 times per day around meals as the placebo beverage.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
108 Participants
n=39 Participants
|
80 Participants
n=29 Participants
|
188 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=39 Participants
|
57 Participants
n=29 Participants
|
126 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
23 Participants
n=29 Participants
|
62 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
25 participants
n=39 Participants
|
14 participants
n=29 Participants
|
39 participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
83 participants
n=39 Participants
|
66 participants
n=29 Participants
|
149 participants
n=60 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=39 Participants
|
80 participants
n=29 Participants
|
188 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 2 MonthsPopulation: Number analyzed differs due to incomplete markers in analysis.
Carcinogen detoxification metabolites in urine. Biomarkers to be analyzed: 2-cyanoethyl mercapturic acid (CEMA), 3-hydroxypropyl mercapturic acid (HPMA1), 2-hydroxypropyl mercapturic acid (HPMA2), phenyl mercapturic acid (SPMA), 3-hydroxy-1-methylpropyl mercapturic acid (HMPMA1), 3-hydroxy-2-methylpropyl mercapturic acid (HMPMA2), and 3-hydroxy-3-methylpropyl mercapturic acid (HMPMA3),
Outcome measures
| Measure |
Freeze Dried Watercress Preparation
n=188 Participants
Freeze dried watercress containing gluconasturtiin, which when added to provided water with flavor powder, will result in a total target dose of up to 40 mg/day of 2-phenethyl isothiocyanate (PEITC). Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
|
Placebo
n=188 Participants
Maltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
|
|---|---|---|
|
Carcinogen Detoxification of Metabolites in Urine.
HPMA1
|
3052.39 ng/mL
Interval 2249.48 to 5009.8
|
1843.29 ng/mL
Interval 1226.52 to 3395.28
|
|
Carcinogen Detoxification of Metabolites in Urine.
HPMA2
|
329.25 ng/mL
Interval 210.08 to 541.68
|
316.70 ng/mL
Interval 183.33 to 494.16
|
|
Carcinogen Detoxification of Metabolites in Urine.
SPMA
|
0.60 ng/mL
Interval 0.34 to 1.49
|
0.44 ng/mL
Interval 0.25 to 0.86
|
|
Carcinogen Detoxification of Metabolites in Urine.
HMPMA1
|
381.91 ng/mL
Interval 281.38 to 507.2
|
307.68 ng/mL
Interval 242.04 to 443.12
|
|
Carcinogen Detoxification of Metabolites in Urine.
HMPMA2
|
218.68 ng/mL
Interval 161.64 to 335.53
|
180.82 ng/mL
Interval 109.18 to 275.83
|
|
Carcinogen Detoxification of Metabolites in Urine.
HMPMA
|
1189.24 ng/mL
Interval 950.12 to 1660.61
|
891.42 ng/mL
Interval 668.65 to 1249.71
|
|
Carcinogen Detoxification of Metabolites in Urine.
HMPMA3
|
518.58 ng/mL
Interval 441.61 to 646.4
|
388.80 ng/mL
Interval 316.68 to 503.75
|
|
Carcinogen Detoxification of Metabolites in Urine.
CEMA
|
7.26 ng/mL
Interval 4.46 to 19.99
|
6.11 ng/mL
Interval 4.12 to 21.94
|
Adverse Events
Freeze Dried Watercress
Serious events: 0 serious events
Other events: 188 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Freeze Dried Watercress
n=300 participants at risk
Freeze dried watercress containing gluconasturtiin, which when added to provided water with flavor powder, will result in a total target dose of up to 40 mg/day of 2-phenethyl isothiocyanate (PEITC). Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
|
Placebo
n=300 participants at risk
Maltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
|
|---|---|---|
|
General disorders
Rash
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Hot Flashes
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Edema (face/neck/limbs/trunk/localized)
|
0.00%
0/300 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
General disorders
Pain (other)
|
0.00%
0/300 • 2 months
|
0.67%
2/300 • Number of events 2 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/300 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/300 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
General disorders
Dysgeusia (change in taste/smell)
|
1.7%
5/300 • Number of events 5 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Headache (incl. migraine)
|
1.3%
4/300 • Number of events 4 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
Psychiatric disorders
Depressed (sad) mood
|
0.33%
1/300 • Number of events 1 • 2 months
|
1.0%
3/300 • Number of events 3 • 2 months
|
|
General disorders
Nightmare/terror
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
Psychiatric disorders
Confusion
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
Gastrointestinal disorders
Increased Urination
|
2.3%
7/300 • Number of events 7 • 2 months
|
3.7%
11/300 • Number of events 11 • 2 months
|
|
General disorders
Nasal congestion (incl. runny nose)
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Saliva, changes in
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Oral dysesthesia (burning/tingling/numbness/pain)
|
7.0%
21/300 • Number of events 21 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
General disorders
Mouth Sore
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
Gastrointestinal disorders
Dyspepsia (upset stomach)
|
1.0%
3/300 • Number of events 3 • 2 months
|
0.00%
0/300 • 2 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux (GERD/heartburn/acid)
|
2.3%
7/300 • Number of events 7 • 2 months
|
1.0%
3/300 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Stomach Pain
|
6.0%
18/300 • Number of events 18 • 2 months
|
1.3%
4/300 • Number of events 4 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
7/300 • Number of events 7 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Nausea
|
10.0%
30/300 • Number of events 30 • 2 months
|
1.7%
5/300 • Number of events 5 • 2 months
|
|
Gastrointestinal disorders
Bloating
|
5.3%
16/300 • Number of events 16 • 2 months
|
1.0%
3/300 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
1.7%
5/300 • Number of events 5 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
15/300 • Number of events 15 • 2 months
|
1.0%
3/300 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Increased gas, belching and changes to stool
|
12.3%
37/300 • Number of events 37 • 2 months
|
2.7%
8/300 • Number of events 10 • 2 months
|
|
General disorders
Fatigue
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Vivid Dreams (see S for nightmare/terror)
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.33%
1/300 • Number of events 1 • 2 months
|
|
General disorders
Appetite, Loss of
|
1.3%
4/300 • Number of events 4 • 2 months
|
0.00%
0/300 • 2 months
|
|
General disorders
Appetite, Increase/hunger
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.00%
0/300 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle aches/pain/spasms)
|
0.33%
1/300 • Number of events 1 • 2 months
|
0.67%
2/300 • Number of events 2 • 2 months
|
|
General disorders
Dizziness/Lightheadedness
|
0.67%
2/300 • Number of events 2 • 2 months
|
0.00%
0/300 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place