Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Environmental Carcinogenesis

Treatments: Drug: Broccoli Sprout-derived Beverage; Drug: Placebos

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02656420

R01CA190610 (U.S. NIH Grant/Contract)

IRB00006734

Details and patient eligibility

About

This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

Full description

This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

Enrollment: 170 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in good general health with no history of chronic illness
• normal liver function tests
• normal renal function tests

Exclusion criteria

• personal history of cancer except for non-melanoma skin cancer
• use of prescribed medicines
• for women, a positive pregnancy test

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

170 participants in 4 patient groups, including a placebo group

Placebos

Placebo Comparator group

Description:

Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.

Treatment:

Drug: Placebos

High Dose Broccoli Sprout

Experimental group

Description:

Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Treatment:

Drug: Broccoli Sprout-derived Beverage

Medium Dose Broccoli Sprout

Experimental group

Description:

Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Treatment:

Drug: Broccoli Sprout-derived Beverage

Low Dose Broccoli Sprout

Experimental group

Description:

Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Treatment:

Drug: Broccoli Sprout-derived Beverage