Clinical trial NCT06561893: Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study
Official title: Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Keywords: broccoli
sulforaphane
probiotic
gut microbiota
L. plantarum
bioavailability
cross-over trial
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: The University of Queensland
name: PepsiCo, Inc.
First posted: 2024-08-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised Double-blind Placebo-controlled Crossover Study
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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 (\&amp;amp;gt;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bioavailability of sulforaphane
timeFrame: 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:
measure: Sulforaphane pharmacokinetics: Area under the curve
timeFrame: 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.
measure: Sulforaphane pharmacokinetics: Cmax
timeFrame: 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.
measure: Sulforaphane pharmacokinetics: Tmax
timeFrame: 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.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: The Department of Public Health and Sport Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter
state: Devon
city: Exeter
country: United Kingdom
facility: Richard's Building, St Luke's Campus
state: Devon
Study officials:
affiliation: University of Exeter
name: Luciana Torquati, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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