NCT02346812

Brief Summary

Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 30, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 15, 2015

Last Update Submit

April 29, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Total isothiocyanates (ITC)

    At the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.

    24-hr

Secondary Outcomes (2)

  • Fecal microbiota

    End of 3-week study period

  • Gastrointestinal health

    8-hr

Study Arms (2)

Brassica

EXPERIMENTAL

Brassica vegetables will be consumed daily as part of a controlled diet.

Other: Controlled diet with brassica vegetables

Control

OTHER

Typical American diet will be consumed, without any Brassica vegetables.

Other: Controlled diet without brassica vegetables

Interventions

Controlled diet without brassica vegetablesOTHER

Participants will be fed a controlled diet containing foods of a typical American diet.

Control
Controlled diet with brassica vegetablesOTHER

Participants will be fed a controlled diet containing foods of a typical American diet.

Brassica

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 21 - 70 years of age
  • Not currently taking glucosinolate/ITC containing supplements
  • Voluntarily agree to participate and sign an informed consent document
  • Free of cancer (never diagnosed or cancer-free for at least 5 y)

You may not qualify if:

  • Pregnant, lactating, or intend to become pregnant during the study period
  • Known allergy or intolerance to Brassica vegetables
  • History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
  • Use of tobacco products
  • Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
  • Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
  • Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
  • Unable or unwilling to give informed consent or communicate with study staff
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Department of Agriculture Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • Charron CS, Vinyard BT, Ross SA, Seifried HE, Jeffery EH, Novotny JA. Absorption and metabolism of isothiocyanates formed from broccoli glucosinolates: effects of BMI and daily consumption in a randomised clinical trial. Br J Nutr. 2018 Dec;120(12):1370-1379. doi: 10.1017/S0007114518002921.

    PMID: 30499426DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physiologist

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 27, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 30, 2015

Record last verified: 2015-01

Locations

US(1)