The Bioavailability Of Sulforaphane From Broccoli Soups Study (BOBS) (BOBS)
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|ClinicalTrials.gov Identifier: NCT02300324|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : September 17, 2015
There is current evidence that suggests eating cruciferous vegetables like broccoli, cauliflower, cabbage is beneficial to our health as they contain compounds which are thought to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs) that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from broccoli is one of the most studied ITCs and its anticancer properties have been extensively investigated in in vitro and in vivo models.
The investigators propose to undertake an intervention study to measure the bioavailability of SF from the soups used in another intervention study called ESCAPE. The investigators would like to investigate the rate and extent to which SF reaches the systemic circulation and is excreted in urine by measuring SF and its metabolites in plasma and urine samples collected from apparently healthy participants after consumption of the three types of broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver different levels of SF.
This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Standard broccoli and stilton soup Dietary Supplement: Beneforte broccoli and stilton soup Dietary Supplement: Beneforte Extra broccoli and stilton soup||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||An Intervention Study to Assess the Bioavailability of Sulforaphane Delivered by Glucoraphanin-enriched Broccoli Soups in Healthy Subjects|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Standard v Beneforte v Beneforte Extra
This is a randomized, double-blinded, three-phase crossover trial investigating the bioavailability of SF following consumption of three types of broccoli + stilton soup containing different concentrations of glucoraphanin. The three types of soup are standard broccoli and stilton soup, beneforte broccoli and stilton soup, and beneforte extra broccoli and stilton soup.
Dietary Supplement: Standard broccoli and stilton soup
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.Dietary Supplement: Beneforte broccoli and stilton soup
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.Dietary Supplement: Beneforte Extra broccoli and stilton soup
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
- Total excretion of SF in 24 hour urine samples [ Time Frame: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours ]To measure the total excretion of SF in urine collected for 24 hours after consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin, SF precursor.
- Plasma concentration of SF and its metabolites [ Time Frame: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and 24 hours ]• To measure SF and its metabolites in plasma following consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300324
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 7UY|
|Principal Investigator:||Richard Mithen, PhD||Quadram Institute|