ObesitySPROUTvsFATNCT03390855
Effects of the Consumption of Broccoli Sprouts in Overweight Subjects
A study testing Broccoli sprouts in people with Obesity and Inflammation, run by Universidad Católica San Antonio de Murcia.
Trial summary
Nowadays there is an increasing demand by consumers on healthy food products prepared in convenient forms, simple to use and not containing additives. In this sense, broccoli sprouts (Brassica oleraceae var. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- Broccoli sprouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI within the overweight range according to the World Health Organization criteria (24.9-29.9 kg/m2), aged 35-55 years, taking no vitamins, supplements or medication during the previous two months; no-smoking.
Who cannot join
- Diagnosed diseases as hypertension and cardiovascular pathologies, diabetes, hepatic, gastrointestinal and renal diseases, as well as the intake of drugs related to these pathologies, vegetarian diet, pregnancy or breastfeeding.
About this study
Nowadays there is an increasing demand by consumers on healthy food products prepared in convenient forms, simple to use and not containing additives. In this sense, broccoli sprouts (Brassica oleraceae var. italica) represent an interesting choice as they are rich in glucosinolates, nitrogen-sulfur compounds, that are believed to counteract the negative effects of diverse pathologies.
Human studies have been focused on the antitumoral properties of these vegetables, however there is less evidence on the anti-inflammatory properties of cruciferous vegetables in humans.
As obesity is linked to an inflammatory component, the aim of the study is to evaluate the anti-inflammatory action of broccoli sprouts in overweight adult subjects.
Read the detailed description
We performed an interventional follow-up study to evaluate the effect of the daily consumption of broccoli sprouts during 10 weeks (70 days). The study was conducted at the Catholic University of Murcia under supervision of Consejo Superior de Investigaciones Científicas (CSIC).
The study was performed according with the Helsinki Declaration of Human Studies and approved by the Ethical Committee of the Catholic University of Murcia as well as the Bioethics Sub-Committee of the CSIC' Department of Ethics for the AGL-2013-46247-P project. Volunteers (n=40; 21 M, 19 W) were recruited in the Catholic University of Murcia (UCAM) and all of them were informed on the characteristics of the study and they signed the written-informed consent. Dietetic and life style habits were recorded from all participants. There were no drop-outs during the whole period of study and no adverse effects were reported due to the broccoli sprout ingestion.
One week before the beginning of the intervention period, subjects were asked to avoid the consumption of Brassica vegetables (broccoli, radish, cauliflower, Brussel sprouts, mustards, among others) and their derived products, and to follow a well-balanced diet (based on Mediterranean diet), with no other food restriction criteria. These dietary instructions were maintained during the entire period of study. Besides, they were requested to record any sign of adverse effect, illness or deviation of the experimental diet. The subjects maintained their usual lifestyles during the study.
On the first day, participants were given the portions of fresh broccoli sprouts to be taken for the whole week (7 trays of broccoli sprouts of 30 g each) and each week they had an appointment to provide them the fresh products. The intervention consisted on a 10-week period which included daily consumption of a portion (30 g) of raw, fresh broccoli sprouts. This amount is consistent with a half- serving according to WHO. Subjects were instructed to ingest 1 tray per day and to keep the trays refrigerated (4º C) at home. The intake of the broccoli sprouts was included in their normal daily diet and no specific time of consumption was established, with the only limitation of avoid cooking of the sprouts and to consume them fresh. Cooking procedures can affect the content of glucosinolates as well as their bioavailability and therefore some recipes were provided to the participants to facilitate the intake of the sprouts without affecting the phytochemical composition and absorption. After the intervention period, a follow-up recovery period for all subjects continued for other 90 days with no ingestion of broccoli sprouts.
Fasting blood samples and 24-h urine samples were taken on day 0 (jst before starting the intervention), day70 (end of intervention period), day 90 (20 days after end of intervention) and day 160 (90 days after end of intervention). Blood samples were collected from each subject by venipuncture from the antecubital vein; 3 mL were placed in heparin tubes and centrifuged at 10000 rpm for 10 min at 4ºC. Plasma was aliquoted and stored at -80ºC until analysis. Analysis were performed once each period was finished and in the same batch to minimize analytical variations. The total volume of the 24h-urine was recorded to calculate the absolute amounts of the compounds and metabolites excreted in the study period and aliquots were frozen at -80ºC for further analysis. Body weight and percentage of fat mass were measured as well and BMI calculated in each sampling time point.
Markers of inflammation as IL-6, C-reactive protein, IL-1β and TNF-α in plasma were determined in our laboratory using high-sensitivity ELISA kits.
Levels of glucosinolates, isothiocyanates and their metabolites were measured in urine by a rapid, sensitive and high throughput UHPLC-QqQ-MS/MS.
- Conditions
- Obesity, Inflammation
- Being tested
- Broccoli sprouts
- Keywords
- IL-6, Glucosinolate, Brassica oleracea, Sulphoraphane, Biomarkers, Bioavailability, Inflammation
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli sproutsOther
| Study group | Role | What they receive |
|---|---|---|
| Broccoli sprout and follow up | Experimental | Daily consumption of 30 g of raw, fresh, broccoli sprouts, not cooked, during 10 weeks (70 days), followed by other 90 days of no ingestion of broccoli sprouts Receives: Other: Broccoli sprouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-6 levels
Plasma levels of IL-6 measured at days 0, 70, 90 and 160 days of intervention
Measured: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Change in C-reactive protein
Plasma levels of C-reactive protein measured at days 0, 70, 90 and 160 days of intervention
Measured: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Secondary outcomes (1)
Bioavailability of glucosinolates from broccoli sprouts
24 h-urine levels of glucosinolates and their metabolites measured by UHPLC-MS/MS
Measured: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention consisted on a 10-week period which included daily consumption of a portion (30 g) of raw, fresh broccoli sprouts. After the intervention period, a follow-up recovery period for all subjects continued for other 90 days with no ingestion of broccoli sprouts.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain
- Responsible party
- Principal investigator, Débora Villaño, Universidad Católica San Antonio de Murcia
- Investigators
- Diego Ángel Moreno Fernández, PhD, Principal investigator, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390855
- Sponsor's protocol ID
- AGL-2013-46247-P
- Acronym
- SPROUTvsFAT
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baenas N, Villano D, Garcia-Viguera C, Moreno DA. Optimizing elicitation and seed priming to enrich broccoli and radish sprouts in glucosinolates. Food Chem. 2016 Aug 1;204:314-319. doi: 10.1016/j.foodchem.2016.02.144. Epub 2016 Feb 26.
PubMed 26988507Baenas N, Suarez-Martinez C, Garcia-Viguera C, Moreno DA. Bioavailability and new biomarkers of cruciferous sprouts consumption. Food Res Int. 2017 Oct;100(Pt 1):497-503. doi: 10.1016/j.foodres.2017.07.049. Epub 2017 Jul 21.
PubMed 28873713Lopez-Chillon MT, Carazo-Diaz C, Prieto-Merino D, Zafrilla P, Moreno DA, Villano D. Effects of long-term consumption of broccoli sprouts on inflammatory markers in overweight subjects. Clin Nutr. 2019 Apr;38(2):745-752. doi: 10.1016/j.clnu.2018.03.006. Epub 2018 Mar 13.
PubMed 29573889
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Consumption of Broccoli Sprouts in Overweight Subjects
- ClinicalTrials.gov ID
- NCT03390855
- Acronym / sponsor ID
- SPROUTvsFAT / AGL-2013-46247-P
- Conditions
- Obesity, Inflammation
- Keywords
- IL-6, Glucosinolate, Brassica oleracea, Sulphoraphane, Biomarkers, Bioavailability, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- National Research Council, Spain
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays there is an increasing demand by consumers on healthy food products prepared in convenient forms, simple to use and not containing additives. In this sense, broccoli sprouts (Brassica oleraceae var. italica) represent an interesting choice as they are rich in glucosinolates, nitrogen-sulfur compounds, that are believed to counteract the negative effects of diverse pathologies.
Human studies have been focused on the antitumoral properties of these vegetables, however there is less evidence on the anti-inflammatory properties of cruciferous vegetables in humans.
As obesity is linked to an inflammatory component, the aim of the study is to evaluate the anti-inflammatory action of broccoli sprouts in overweight adult subjects.
Detailed description
We performed an interventional follow-up study to evaluate the effect of the daily consumption of broccoli sprouts during 10 weeks (70 days). The study was conducted at the Catholic University of Murcia under supervision of Consejo Superior de Investigaciones Científicas (CSIC).
The study was performed according with the Helsinki Declaration of Human Studies and approved by the Ethical Committee of the Catholic University of Murcia as well as the Bioethics Sub-Committee of the CSIC' Department of Ethics for the AGL-2013-46247-P project. Volunteers (n=40; 21 M, 19 W) were recruited in the Catholic University of Murcia (UCAM) and all of them were informed on the characteristics of the study and they signed the written-informed consent. Dietetic and life style habits were recorded from all participants. There were no drop-outs during the whole period of study and no adverse effects were reported due to the broccoli sprout ingestion.
One week before the beginning of the intervention period, subjects were asked to avoid the consumption of Brassica vegetables (broccoli, radish, cauliflower, Brussel sprouts, mustards, among others) and their derived products, and to follow a well-balanced diet (based on Mediterranean diet), with no other food restriction criteria. These dietary instructions were maintained during the entire period of study. Besides, they were requested to record any sign of adverse effect, illness or deviation of the experimental diet. The subjects maintained their usual lifestyles during the study.
On the first day, participants were given the portions of fresh broccoli sprouts to be taken for the whole week (7 trays of broccoli sprouts of 30 g each) and each week they had an appointment to provide them the fresh products. The intervention consisted on a 10-week period which included daily consumption of a portion (30 g) of raw, fresh broccoli sprouts. This amount is consistent with a half- serving according to WHO. Subjects were instructed to ingest 1 tray per day and to keep the trays refrigerated (4º C) at home. The intake of the broccoli sprouts was included in their normal daily diet and no specific time of consumption was established, with the only limitation of avoid cooking of the sprouts and to consume them fresh. Cooking procedures can affect the content of glucosinolates as well as their bioavailability and therefore some recipes were provided to the participants to facilitate the intake of the sprouts without affecting the phytochemical composition and absorption. After the intervention period, a follow-up recovery period for all subjects continued for other 90 days with no ingestion of broccoli sprouts.
Fasting blood samples and 24-h urine samples were taken on day 0 (jst before starting the intervention), day70 (end of intervention period), day 90 (20 days after end of intervention) and day 160 (90 days after end of intervention). Blood samples were collected from each subject by venipuncture from the antecubital vein; 3 mL were placed in heparin tubes and centrifuged at 10000 rpm for 10 min at 4ºC. Plasma was aliquoted and stored at -80ºC until analysis. Analysis were performed once each period was finished and in the same batch to minimize analytical variations. The total volume of the 24h-urine was recorded to calculate the absolute amounts of the compounds and metabolites excreted in the study period and aliquots were frozen at -80ºC for further analysis. Body weight and percentage of fat mass were measured as well and BMI calculated in each sampling time point.
Markers of inflammation as IL-6, C-reactive protein, IL-1β and TNF-α in plasma were determined in our laboratory using high-sensitivity ELISA kits.
Levels of glucosinolates, isothiocyanates and their metabolites were measured in urine by a rapid, sensitive and high throughput UHPLC-QqQ-MS/MS.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention consisted on a 10-week period which included daily consumption of a portion (30 g) of raw, fresh broccoli sprouts. After the intervention period, a follow-up recovery period for all subjects continued for other 90 days with no ingestion of broccoli sprouts.
| Arm | Type | Receives |
|---|---|---|
| Broccoli sprout and follow up | Experimental | Other: Broccoli sproutsDaily consumption of 30 g of raw, fresh, broccoli sprouts, not cooked, during 10 weeks (70 days), followed by other 90 days of no ingestion of broccoli sprouts |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI within the overweight range according to the World Health Organization criteria (24.9-29.9 kg/m2), aged 35-55 years, taking no vitamins, supplements or medication during the previous two months; no-smoking.
Key exclusion criteria (1 listed)
- Diagnosed diseases as hypertension and cardiovascular pathologies, diabetes, hepatic, gastrointestinal and renal diseases, as well as the intake of drugs related to these pathologies, vegetarian diet, pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli sprouts | Other | Broccoli sprout and follow up |
Primary outcome
Change in IL-6 levels
Time frame: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Plasma levels of IL-6 measured at days 0, 70, 90 and 160 days of intervention
Change in C-reactive protein
Time frame: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Plasma levels of C-reactive protein measured at days 0, 70, 90 and 160 days of intervention
1 secondary outcome
Bioavailability of glucosinolates from broccoli sprouts
Time frame: Changes observed from baseline at day 0 compared to 70, 90, 160 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Background: PubMed 26988507Baenas N, Villano D, Garcia-Viguera C, Moreno DA. Optimizing elicitation and seed priming to enrich broccoli and radish sprouts in glucosinolates. Food Chem. 2016 Aug 1;204:314-319. doi: 10.1016/j.foodchem.2016.02.144. Epub 2016 Feb 26.
- Background: PubMed 28873713Baenas N, Suarez-Martinez C, Garcia-Viguera C, Moreno DA. Bioavailability and new biomarkers of cruciferous sprouts consumption. Food Res Int. 2017 Oct;100(Pt 1):497-503. doi: 10.1016/j.foodres.2017.07.049. Epub 2017 Jul 21.
- Derived from this study: PubMed 29573889Lopez-Chillon MT, Carazo-Diaz C, Prieto-Merino D, Zafrilla P, Moreno DA, Villano D. Effects of long-term consumption of broccoli sprouts on inflammatory markers in overweight subjects. Clin Nutr. 2019 Apr;38(2):745-752. doi: 10.1016/j.clnu.2018.03.006. Epub 2018 Mar 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Ángel Moreno Fernández, PhD principal investigator
National Research Council, Spain
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli sprouts in people with Obesity and Inflammation, run by Universidad Católica San Antonio de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-6 levels (time frame: Changes observed from baseline at day 0 compared to 70, 90, 160 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390855, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.