NCT03390855

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable obesity

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

February 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

December 28, 2017

Last Update Submit

December 28, 2017

Conditions

Keywords

IL-6GlucosinolateBrassica oleraceaSulphoraphaneBiomarkersBioavailabilityInflammation

Outcome Measures

Primary Outcomes (2)

  • Change in IL-6 levels

    Plasma levels of IL-6 measured at days 0, 70, 90 and 160 days of intervention

    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

    Changes observed from baseline at day 0 compared to 70, 90, 160 days

Secondary Outcomes (1)

  • Bioavailability of glucosinolates from broccoli sprouts

    Changes observed from baseline at day 0 compared to 70, 90, 160 days

Study Arms (1)

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

Other: Broccoli sprouts

Interventions

Broccoli sprout and follow up

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26988507BACKGROUND
  • 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.

    PMID: 28873713BACKGROUND
  • 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.

MeSH Terms

Conditions

ObesityInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Diego Ángel Moreno Fernández, PhD

    National Research Council, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

January 4, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share