Ignite Creation Date:
2025-12-18 @ 8:11 AM
Ignite Modification Date:
2025-12-18 @ 8:11 AM
Study NCT ID:
NCT02300324
Status:
None
Last Update Posted:
2015-09-17 00:00:00
First Post:
2014-11-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Bioavailability Of Sulforaphane From Broccoli Soups Study (BOBS)
Sponsor:
None
Organization:
Study Overview
Official Title:
An Intervention Study to Assess the Bioavailability of Sulforaphane Delivered by Glucoraphanin-enriched Broccoli Soups in Healthy Subjects
Status:
None
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOBS
Brief Summary:
This study will be a randomized, double-blinded, three-phase crossover trial which will investigate the bioavailability of SF following consumption of broccoli + stilton soup containing different concentrations of glucoraphanin.
The study population will consist of non-smoking men and women aged between 18 and 65 years old. Participants will undergo three phases separated by a minimum of two weeks (wash-out period). Each phase will consist of a 48 hour pre-intervention diet restriction, a study day involving an 8 hour cannulation at the Human Nutrition Unit (HNU) of the Institute of Food Research (IFR) and collection of a 24 hour urine and blood sample the following morning. Participants will be randomly allocated to one of the three soups in each phase. The following soups will be tested in the three phases: i) 300g standard broccoli + stilton soup, ii) 300g Beneforte® broccoli + stilton soup, iii) 300g Beneforte Extra broccoli + stilton soup.
Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom.
Each phase will consist of a 48 hour pre-intervention diet restriction, a study day (study day 1) comprising of approximately a nine hour stay at the HNU which will involve cannulation. The following morning participants will visit the HNU for up to 1 hour for collection of a single blood sample at 24 hour post-dose followed by breakfast. During study day 1, eleven 10ml blood samples will be collected over the course of the day from participants at the following timepoints: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and a 24 hour blood sample. Six urine samples will be collected at the following timepoints: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours.
The three phases will be separated by a minimum of a two week washout period. For the duration of the study, participants will be required to follow a glucosinolate-free diet for a total of nine days which will be three days per phase. The three days are split into 48 hours (2 days) prior to the study day, 24 hours (1 day) on the study day as well as the following morning until the 24 hour blood and urine sample have been collected. After the 24 hour urine and blood samples have been collected, participants can resume their normal diet for a minimum of two weeks until 48 hours prior to their next study day. This will reduce the contribution of glucosinolate from other foods having an impact on the results of the study. The involvement of the participants will last approximately 11-12 weeks.
The study population will consist of non-smoking men and women aged between 18 and 65 years old. Participants will undergo three phases separated by a minimum of two weeks (wash-out period). Each phase will consist of a 48 hour pre-intervention diet restriction, a study day involving an 8 hour cannulation at the Human Nutrition Unit (HNU) of the Institute of Food Research (IFR) and collection of a 24 hour urine and blood sample the following morning. Participants will be randomly allocated to one of the three soups in each phase. The following soups will be tested in the three phases: i) 300g standard broccoli + stilton soup, ii) 300g Beneforte® broccoli + stilton soup, iii) 300g Beneforte Extra broccoli + stilton soup.
Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom.
Each phase will consist of a 48 hour pre-intervention diet restriction, a study day (study day 1) comprising of approximately a nine hour stay at the HNU which will involve cannulation. The following morning participants will visit the HNU for up to 1 hour for collection of a single blood sample at 24 hour post-dose followed by breakfast. During study day 1, eleven 10ml blood samples will be collected over the course of the day from participants at the following timepoints: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and a 24 hour blood sample. Six urine samples will be collected at the following timepoints: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours.
The three phases will be separated by a minimum of a two week washout period. For the duration of the study, participants will be required to follow a glucosinolate-free diet for a total of nine days which will be three days per phase. The three days are split into 48 hours (2 days) prior to the study day, 24 hours (1 day) on the study day as well as the following morning until the 24 hour blood and urine sample have been collected. After the 24 hour urine and blood samples have been collected, participants can resume their normal diet for a minimum of two weeks until 48 hours prior to their next study day. This will reduce the contribution of glucosinolate from other foods having an impact on the results of the study. The involvement of the participants will last approximately 11-12 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: