Sulforaphane Supplementation Study

NCT04364360 | Unknown

• 1 other identifier: 1439
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome

Keywords

Sulforaphane; NAFLD

Outcome Measures

Primary Outcomes (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.

  within 7 days after completion of the intervention

Secondary Outcomes (3)

• Change in liver fat content

  within 7 days after completion of the intervention

• Change in hepatic fatty acid partitioning

  within 7 days after completion of the intervention

• Change in glycemic control

  within 7 days after completion of the intervention

Study Arms (1)

Sulforaphane supplementation

EXPERIMENTAL

Daily (2 capsules) consumption of BroccoMax (Jarrow Formulas Los Angeles, CA) for 3-weeks.

Dietary Supplement: Sulforaphane extract

Interventions

Sulforaphane extract DIETARY_SUPPLEMENT

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

Sulforaphane 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:

• 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. -

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Leanne Hodson, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sion A Parry, PhD

CONTACT

+447976359081; sion.parry@ocdem.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group intervention

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 28, 2020
• Study Start: January 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)