Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

NCT ID: NCT02656420

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed 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.

Conditions

Environmental Carcinogenesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebos

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo as comparison to broccoli sprout-derived beverages

High Dose Broccoli Sprout

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.

Group Type: EXPERIMENTAL

Broccoli Sprout-derived Beverage

Intervention Type: DRUG

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

Medium Dose Broccoli Sprout

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.

Group Type: EXPERIMENTAL

Broccoli Sprout-derived Beverage

Intervention Type: DRUG

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

Low Dose Broccoli Sprout

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.

Group Type: EXPERIMENTAL

Broccoli Sprout-derived Beverage

Intervention Type: DRUG

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

Interventions

Broccoli Sprout-derived Beverage

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

Intervention Type: DRUG

Placebos

Placebo as comparison to broccoli sprout-derived beverages

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qidong Liver Cancer Institute

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Kensler, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Qidong Liver Cancer Institute

Qidong, Jiangsu, China

Countries

China

References

Egner PA, Chen JG, Zarth AT, Ng DK, Wang JB, Kensler KH, Jacobson LP, Munoz A, Johnson JL, Groopman JD, Fahey JW, Talalay P, Zhu J, Chen TY, Qian GS, Carmella SG, Hecht SS, Kensler TW. Rapid and sustainable detoxication of airborne pollutants by broccoli sprout beverage: results of a randomized clinical trial in China. Cancer Prev Res (Phila). 2014 Aug;7(8):813-823. doi: 10.1158/1940-6207.CAPR-14-0103. Epub 2014 Jun 9.

Reference Type: BACKGROUND

PMID: 24913818 (View on PubMed)

Chen JG, Johnson J, Egner P, Ng D, Zhu J, Wang JB, Xue XF, Sun Y, Zhang YH, Lu LL, Chen YS, Wu Y, Zhu YR, Carmella S, Hecht S, Jacobson L, Munoz A, Kensler K, Rule A, Fahey J, Kensler T, Groopman J. Dose-dependent detoxication of the airborne pollutant benzene in a randomized trial of broccoli sprout beverage in Qidong, China. Am J Clin Nutr. 2019 Sep 1;110(3):675-684. doi: 10.1093/ajcn/nqz122.

Reference Type: DERIVED

PMID: 31268126 (View on PubMed)

Other Identifiers

R01CA190610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00006734

Identifier Type: -

Identifier Source: org_study_id