Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study

NCT06561893 | Completed

• 1 other identifier: 6190780
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Broccoli has the precursor of an active compound (sulforaphane) that has shown a wide range of health promoting benefits. Sulforaphane formation depends on the conversion of glucoraphanin (precursor) by myrosinase enzyme. Thus, the bioavailability of sulforaphane is affected by myrosinase activity. Some bacteria, such as L. plantarum (probiotic), have shown they can also convert glucoraphanin to sulforaphane in vitro. This study investigates the effect of short-term L. plantarum supplementation on broccoli sulforaphane bioavailability in humans using a randomised double-blind placebo-controlled crossover trial.

Conditions

Nutrition, Healthy

Keywords

broccoli; sulforaphane; probiotic; gut microbiota; L. plantarum; bioavailability; cross-over trial

Outcome Measures

Primary Outcomes (1)

• Bioavailability of sulforaphane

  Bioavailability (%) of sulforaphane (will be estimated by dividing the cumulative amount of sulforaphane mercapturic acid excreted in urine in 24 h by the consumed amount of glucoraphanin (Vermeulen et al., 2008)) before and after chronic consumption of L. plantarum compared with placebo.

  From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition

Secondary Outcomes (3)

• Sulforaphane pharmacokinetics: Area under the curve

  From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.

• Sulforaphane pharmacokinetics: Cmax

  From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.

• Sulforaphane pharmacokinetics: Tmax

  From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.

Study Arms (2)

Probiotic (L. plantarum) supplementation

ACTIVE COMPARATOR

Dose: 20 Billion CFU/day for 14 days (total of two pills of 10 Billion CFU)

Dietary Supplement: Broccoli sprouts extract supplementation

Placebo (dextrose) supplementation

PLACEBO COMPARATOR

Dose: 700 mg of dextrose (total of two pills; 2 x 350 mg pills)

Dietary Supplement: Broccoli sprouts extract supplementation

Interventions

Broccoli sprouts extract supplementation DIETARY_SUPPLEMENT

Intake of broccoli sprouts extract supplement (Brand: Source Naturals, Scotts Valley, CA 95066 - USA) in an acute dose (84 umol of glucoraphanin) before and after 2 weeks of probiotic or placebo supplementation, to assess sulforaphane bioavailability measured in urine metabolites

Placebo (dextrose) supplementation; Probiotic (L. plantarum) supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults (male and female)
• age range of 18-65 years
• BMI range of 18-30 kg/m2

You may not qualify if:

• have been on a course of antibiotics within the period of the past 3 months.
• have allergies or intolerance towards probiotic substances or broccoli used in the study and/or food intolerances associated with gastrointestinal upset.
• have been taking pre- or probiotics supplements regularly during the last month prior (this does not include foods containing probiotics and/or prebiotics foods)
• are following any restricting diet (e.g., vegan, FODMAP, etc.).
• have a gastrointestinal inflammatory condition (e.g., irritable bowel syndrome, inflammatory bowel diseases, coeliac diseases, constipation, etc.).
• have a medical condition or take medication for any heart, endocrine, or metabolic condition, such as high blood pressure, high cholesterol, insulin resistance, or diabetes, or autoimmune disease.
• are a pregnant and/or breastfeeding.

Sponsors & Collaborators

• University of Exeter: lead
• The University of Queensland: collaborator
• PepsiCo, Inc.: collaborator

Study Sites (2)

The Department of Public Health and Sport Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter

Exeter, Devon, EX1 2 LU, United Kingdom

Location

Richard's Building, St Luke's Campus

Exeter, Devon, EX2 4TA, United Kingdom

Location

Related Publications (7)

• Oloyede OO, Wagstaff C, Methven L. The Impact of Domestic Cooking Methods on Myrosinase Stability, Glucosinolates and Their Hydrolysis Products in Different Cabbage (Brassica oleracea) Accessions. Foods. 2021 Nov 24;10(12):2908. doi: 10.3390/foods10122908.

  PMID: 34945460 BACKGROUND

• Gonzalez F, Quintero J, Del Rio R, Mahn A. Optimization of an Extraction Process to Obtain a Food-Grade Sulforaphane-Rich Extract from Broccoli (Brassica oleracea var. italica). Molecules. 2021 Jul 1;26(13):4042. doi: 10.3390/molecules26134042.

  PMID: 34279379 BACKGROUND

• Iahtisham-Ul-Haq, Khan S, Awan KA, Iqbal MJ. Sulforaphane as a potential remedy against cancer: Comprehensive mechanistic review. J Food Biochem. 2022 Mar;46(3):e13886. doi: 10.1111/jfbc.13886. Epub 2021 Aug 5.

  PMID: 34350614 BACKGROUND

• Surono IS, Simatupang A, Kusumo PD, Waspodo P, Verbruggen S, Verhoeven J, Venema K. Effect of Different Functional Food Supplements on the Gut Microbiota of Prediabetic Indonesian Individuals during Weight Loss. Nutrients. 2022 Feb 13;14(4):781. doi: 10.3390/nu14040781.

  PMID: 35215431 BACKGROUND

• Ye JH, Huang LY, Terefe NS, Augustin MA. Fermentation-based biotransformation of glucosinolates, phenolics and sugars in retorted broccoli puree by lactic acid bacteria. Food Chem. 2019 Jul 15;286:616-623. doi: 10.1016/j.foodchem.2019.02.030. Epub 2019 Feb 14.

  PMID: 30827654 BACKGROUND

• Cai YX , Augustin MA , Jegasothy H , Wang JH , Terefe NS . Mild heat combined with lactic acid fermentation: a novel approach for enhancing sulforaphane yield in broccoli puree. Food Funct. 2020 Jan 29;11(1):779-786. doi: 10.1039/c9fo02089f.

  PMID: 31922158 BACKGROUND

• Vermeulen M, Klopping-Ketelaars IW, van den Berg R, Vaes WH. Bioavailability and kinetics of sulforaphane in humans after consumption of cooked versus raw broccoli. J Agric Food Chem. 2008 Nov 26;56(22):10505-9. doi: 10.1021/jf801989e.

  PMID: 18950181 BACKGROUND

Study Officials

• Luciana Torquati, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Double-blind Placebo-controlled Crossover Study

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: August 20, 2024
• Study Start: October 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)