search
Back to results

Effects of the Consumption of Broccoli Sprouts in Overweight Subjects (SPROUTvsFAT)

Primary Purpose

Obesity, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Broccoli sprouts
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring IL-6, Glucosinolate, Brassica oleracea, Sulphoraphane, Biomarkers, Bioavailability, Inflammation

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Broccoli sprout and follow up

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in IL-6 levels
    Plasma levels of IL-6 measured at days 0, 70, 90 and 160 days of intervention
    Change in C-reactive protein
    Plasma levels of C-reactive protein measured at days 0, 70, 90 and 160 days of intervention

    Secondary Outcome Measures

    Bioavailability of glucosinolates from broccoli sprouts
    24 h-urine levels of glucosinolates and their metabolites measured by UHPLC-MS/MS

    Full Information

    First Posted
    December 28, 2017
    Last Updated
    December 28, 2017
    Sponsor
    Universidad Católica San Antonio de Murcia
    Collaborators
    National Research Council, Spain
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03390855
    Brief Title
    Effects of the Consumption of Broccoli Sprouts in Overweight Subjects
    Acronym
    SPROUTvsFAT
    Official Title
    Effects of the Consumption of Broccoli Sprouts in Overweight Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica San Antonio de Murcia
    Collaborators
    National Research Council, Spain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Inflammation
    Keywords
    IL-6, Glucosinolate, Brassica oleracea, Sulphoraphane, Biomarkers, Bioavailability, Inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Broccoli sprout and follow up
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Broccoli sprouts
    Primary Outcome Measure Information:
    Title
    Change in IL-6 levels
    Description
    Plasma levels of IL-6 measured at days 0, 70, 90 and 160 days of intervention
    Time Frame
    Changes observed from baseline at day 0 compared to 70, 90, 160 days
    Title
    Change in C-reactive protein
    Description
    Plasma levels of C-reactive protein measured at days 0, 70, 90 and 160 days of intervention
    Time Frame
    Changes observed from baseline at day 0 compared to 70, 90, 160 days
    Secondary Outcome Measure Information:
    Title
    Bioavailability of glucosinolates from broccoli sprouts
    Description
    24 h-urine levels of glucosinolates and their metabolites measured by UHPLC-MS/MS
    Time Frame
    Changes observed from baseline at day 0 compared to 70, 90, 160 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diego Ángel Moreno Fernández, PhD
    Organizational Affiliation
    National Research Council, Spain
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26988507
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28873713
    Citation
    Baenas 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.
    Results Reference
    background
    PubMed Identifier
    29573889
    Citation
    Lopez-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.
    Results Reference
    derived

    Learn more about this trial

    Effects of the Consumption of Broccoli Sprouts in Overweight Subjects

    We'll reach out to this number within 24 hrs