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Non-Alcoholic Fatty Liver DiseaseFAMOUSNCT04364360

Sulforaphane Supplementation Study

A study testing Sulforaphane extract in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Oxford at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Non-alcoholic fatty liver disease (NAFLD) is increasing in the population, and is associated with heart disease and diabetes. At present there are no licensed drugs for treatment of NAFLD, therefore changes in diet and increased physical activity leading to decreased body fatness is the recommended… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Sulforaphane extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
1 Jan 2020to Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the study.
  • Healthy adults, Male or Female, aged 18 to 65 years.
  • No medical condition or relevant drug therapy known to affect glucose or fatty acid metabolism.
  • Weight stable for the previous 3 months. -

Who cannot join

  • Aged ≤18 or ≥65 years.
  • Body Mass Index ≤19 or ≥35kg/m2.
  • Females with a body mass ≤50kg.
  • A blood haemoglobin <135mg/dL for men and <120mg/dL for women.
  • Donated (or lost) ≥250 ml of blood in the previous two months.
  • On a weight loss diet or have decreased their body weight by >5% in the previous 3 months.
Show all 19Show fewer
  • Have increased their body weight by >5% in the previous 3 months.
  • Any metabolic condition or relevant drug therapy known to affect glucose or fatty acid metabolism.
  • Smoking, or use of nicotine replacement agents (e.g. e-cigarettes).
  • History of alcoholism or a greater than recommended alcohol intake (>30 g of alcohol daily for men and >20 g of alcohol daily for women).
  • Current or history of Haemorrhagic disorders.
  • History of albumin allergy or allergic to eggs
  • Current or history of anticoagulant treatment.
  • Pregnant or nursing mothers.
  • Women prescribed any hormone replacement therapy (HRT) or who have used these within the last 12 months.
  • History of severe claustrophobia.
  • Presence of metallic implants, pacemaker, or inability/unwillingness to remove any piercings, and any large tattoos around the area to be scanned.
  • History or current psychiatric illness.
  • History or current neurological condition (e.g. epilepsy).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Oxford Centre for Diabetes, Endocrinology and Metabolism

    Oxford, Oxfordshire, OX3 7LE

    Louise Dennis, MSc, +441865857203, louise.dennis@ocdem.ox.ac.uk

    Rachel Craven-Todd, +441865857331, rachel.craven-todd@ocdem.ox.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Fatty Acid MetabOlism in Individuals Undergoing Sulforaphane Supplementation (FAMOUS)

Non-alcoholic fatty liver disease (NAFLD) is increasing in the population, and is associated with heart disease and diabetes. At present there are no licensed drugs for treatment of NAFLD, therefore changes in diet and increased physical activity leading to decreased body fatness is the recommended management/treatment strategy. However, these are difficult to achieve and maintain for many individuals. A potential compound gaining interest in regards the treatment/prevention of NAFLD is sulforaphane, which is found in vegetables such as Broccoli. Animal studies suggest supplementing with sulforaphane can increase fat oxidation. This increased "fat burning" may result in lower levels of fat in the liver and overall in the body.

The researchers will ask participants to undertake an intervention phase which will involve consuming two sulforaphane tablets a day for approximately 3 weeks. Participants will be asked to maintain all other aspects of their lifestyle throughout the intervention phase. The researchers will measure and compare participants whole-body and liver fat oxidation in response to a standardised test meal before and after the intervention phase by taking blood and breath samples. The researchers will also measure the amount of fat in participants liver and heart using a non-invasive technique known as magnetic resonance spectroscopy (MRS) before and after the intervention.

Read the detailed description

Participants satisfying the inclusion criteria will be invited to the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), to measure the amount of fat within their liver and heart using magnetic resonance imaging and spectroscopy (MRI/S). Then on a separate day, within one week of having their liver and heart fat content measured, participants will come into the Clinical Research Unit (CRU) at the Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM) for a 'postprandial study day' after an overnight fast. Participants will be asked to avoid excessive exercise and alcohol for 24 hours prior to the study. The day prior to and over the course of the 'study day' participants will be asked to drink some 'heavy water' ((2H2O) CK Isotopes Limited). The amount of 'heavy water' a volunteer will have to consume is 3g heavy water per kg body water, which will achieve a plasma water enrichment of 0.3%. Once participants arrive at OCDEM the researchers will make some anthropometric measurements (e.g. weight, height, waist circumference etc.), collect a urine sample, and place a small plastic tube (cannula) into a vein on the forearm, from which they will take blood samples. A second cannula will also be placed into a large vein in the elbow crease of the opposite arm. Sequential blood samples will be collected by the researchers at regular intervals for a period of up to 8 hours from placing the first cannula. After the first blood samples have been taken (Time -30) the researchers will start pumping fat labelled with special atoms (stable isotopes from CK Isotopes Limited) into the other cannula. After approximately 30 minutes of infusion, a second blood sample (time 0) will be taken, after which participants will be fed a standardised test meal which will consist of cereal and semi-skimmed milk and a "fatty" chocolate drink. The fatty chocolate drink is made with a blend of oils and will be labelled with a stable isotope (from CK Isotopes Limited). The use of the stable isotopes in small doses is considered to be completely harmless (it is not radioactive). Once the test meal is consumed, the volunteer is free to rest on a bed or in a chair, as they prefer, until the experiment is finished, up to 8 hours. After giving the stable isotopes, blood and breath samples will be taken initially every 30 minutes for the first two hours and then every 60 minutes up until the end of the study day (6 hours post breakfast). The researchers would take blood samples through the cannula in the vein, and at each time point would take approx. 25ml of blood. The most blood taken in total over the day would be 250ml or approximately 1/2 of a pint.

Three hours after consumption of the test breakfast meal the researchers will take two adipose tissue biopsies. The first biopsy will be taken from the fat just under the skin in the abdomen (tummy) and the second biopsy will be taken from the gluteal (buttock) region. There will be numbing of the skin and fat tissue as a local anaesthetic (1% lignocaine) is used prior to all biopsies. The choice as to whether or not to undergo biopsies will be given to participants on the study day. At some point during the day a dual energy X-ray absorptiometry (DEXA) scan will be performed. The DEXA scan will measure the total amount of fat (adipose tissue) along with the amount of adipose tissue in specific depots (e.g. upper body, lower body, visceral etc.). When all of the samples have been taken and the measurements are finished, the researchers would take out the plastic tubes, and give the participant something further to eat and drink before making sure they can get home, usually by providing them with a taxi. Participants will also be provided with the sulforaphane capsules to be ingested over the following 3-week period, and guidelines as to when to take supplements. Participants will be asked to maintain their habitual diets during the intervention phase, which will be assessed via the completion of food diaries where all foods and beverages consumed on 3 days a week (two week and one weekend day) each week of the 3 week intervention phase. A member of the research team will be in regular contact with participants via email throughout the intervention phase in an attempt to maintain compliance. Following the 3-week intervention phase the volunteer's liver and heart fat content will again be measured using MRI/S at OCMR, then on a separate day, within one week of having their liver and heart fat content measured, participants will come into the CRU at OCDEM for a second 'study day' after an overnight fast. The second 'study day' will be identical to the first study day described above.

Being tested
Sulforaphane extract
Keywords
Sulforaphane, NAFLD
Medical subject headings
Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulforaphane extractDietary supplement

    2x BroccoMax® capsules day, giving a total daily dose of 30 mg of Sulforaphane Glucosinolate Per day

Study groups in NCT04364360
Study groupRoleWhat they receive
Sulforaphane supplementationExperimentalDaily (2 capsules) consumption of BroccoMax (Jarrow Formulas Los Angeles, CA) for 3-weeks.
Receives: Dietary Supplement: Sulforaphane extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in whole-body fatty acid oxidation

    Stable-isotope tracers will be used to measure whole-body dietary fatty acid oxidation in response to a standardised test meal before and after the intervention.

    Measured: within 7 days after completion of the intervention

Secondary outcomes (3)
  1. Change in liver fat content

    MRI/S will be used to measures liver fat content before and after the intervention.

    Measured: within 7 days after completion of the intervention

  2. Change in hepatic fatty acid partitioning

    Stable-isotope tracers will be used to measure whole-body and hepatic fatty acid metabolism in response to a standardised test meal before and after the intervention.

    Measured: within 7 days after completion of the intervention

  3. Change in glycemic control

    Participants postprandial glycemic control will be measured following a standardised test meal before and after the intervention.

    Measured: within 7 days after completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start1 Jan 2020
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Single group intervention
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364360
Sponsor's protocol ID
1439
Acronym
FAMOUS
Status last verified
Jun 2022
First submitted
6 Apr 2020
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sulforaphane extract in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sion A Parry, PhD (+447976359081, sion.parry@ocdem.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in whole-body fatty acid oxidation (time frame: within 7 days after completion of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022; AzTrials last refreshed its copy on 28 Oct 2026.

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