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Completed

NCT Number: NCT06561893

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard's Building, St Luke's Campus, Exeter, Devon, United Kingdom

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About this study

Brassicas (i.e. broccoli, kale, cabbage) are a group of edible plants that contain a phytochemical called glucoraphanin that upon enzymatic hydrolysis forms the bioactive form sulforaphane. Sulforaphane has shown consistent in vitro and in vivo (animals) anti-cancer activity. The enzyme responsible for this conversion is called myrosinase; however, the enzymatic activity of myrosinase can be affected by several biological factors (e.g. plant variety, growth conditions, etc...) and food processing (e.g. cooking, drying, etc...). Broccoli is one of the richest sources of glucoraphanin, but its myrosinase activity can be easily lost during cooking: 10 minutes at 70 °C reduces the enzyme activity by 95%. This means broccoli prepared this way will contain little to no biologically active sulforaphane. Therefore, is important to find strategies to increase the bioavailability of sulforaphane in broccoli and other brassicas for human consumption.

Certain bacteria have shown myrosinase-like activity and were able to convert glucoraphanin to sulforaphane in vitro, one of these bacteria is Lactiplantibacillus plantarum. This bacterium is present in the human gut, however, there is a large biological variability in the prevalence of this bacteria between individuals. Several human studies have demonstrated that chronic (>1 week) consumption of probiotic supplements containing L. plantarum was able to increase the presence of this bacterium in human gut participants. Thus, the investigators aim to test if supplementing participants with L. plantarum will increase the bioavailability of sulforaphane, compared to placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Bioavailability of sulforaphane

    Time frame: 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

    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.

Secondary outcomes

  1. Sulforaphane pharmacokinetics: Area under the curve

    Time frame: 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.

    Measurement of the definite integral of the concentration of sulforaphane (and its metabolites) in blood plasma as a function of time.

  2. Sulforaphane pharmacokinetics: Cmax

    Time frame: 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.

    Measurement of the maximum plasma concentration (Cmax) of sulforaphane (and its metabolites) indicating the value of the highest concentrations reached in the plasma.

  3. Sulforaphane pharmacokinetics: Tmax

    Time frame: 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.

    Measurement of the time taken for sulforaphane (and its metabolites) to reach the maximum concentration (Cmax) after administration of the supplement that needs to be absorbed.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • PepsiCo, Inc.
  • The University of Queensland

Registry information

Acronym: PRO-BROC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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