Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes

NCT02801448 | Completed Phase 2

• 1 other identifier: BSE1
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from pancreatic islets and insulin resistance of target cells. The investigators have extensive pre-clinical data suggesting that BSE through its high content of the isothiocyanate sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could therefore benefit both patients with T2D and individuals at risk for the disease. BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The investigators aim to study the clinical effect of using BSE as a dietary supplement on glucose tolerance and insulin sensitivity.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Delta-HbA1c

  difference in HbA1c before and after treatment

  12 weeks

Secondary Outcomes (1)

• Delta-fasting blood glucose

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo containing maltodextrine but no active sulforaphane

Drug: Placebo

BSE

ACTIVE COMPARATOR

Broccoli sprout extract once daily for 12 weeks

Drug: sulforaphane

Interventions

sulforaphane DRUG

sulforaphane-containing broccoli sprout extracts

BSE

Placebo DRUG

Maltodextrine-based placebo without sulforaphane

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classified as type 2 diabetes
• Written informed consent
• Age: for men and women 35-75 years; for women below 75 years should be postmenopausal (defined as no menstrual bleeding since at least one year).
• Body mass index 25-40 kg/m2
• At screening visit : HbA1c 6-10 %, equivalent to 41-86 mmol/mol
• Currently treated with metformin or diet

You may not qualify if:

• Treatment with insulin, other anti-diabetic treatment given as injections or any oral anti-diabetic treatment except metformin
• Fasting blood glucose at screening \> 15.0 mmol/L
• Active liver disease
• At screening or at any subsequent visit a level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) of more than three times the upper limit of the normal range
• Gastrointestinal ailments which may interfere with the ability to adequately absorb sulforaphane
• At screening visit creatinine \> 130 µmol/L
• Coagulation disorder or current anti-coagulant therapy with warfarin, which may be affected by the BSE
• Diagnosed with a cardiovascular disease or event within 6 months prior to enrolment
• Systemic glucocorticoid treatment
• Herbal treatment, defined as food supplement (except multivitamin treatment) with herbal or vegetable extracts that may contain sulforaphane
• Allergy to broccoli
• Mental disorder making the patient unable to understand the study information
• Participation in other clinical trial which may affect the outcome of the present study
• Any other physical or psychiatric condition or treatment that in the judgment of the investigator makes it difficult to participate in the study.

Sponsors & Collaborators

• Anders Rosengren, MD PhD: lead

Related Publications (1)

• Axelsson AS, Tubbs E, Mecham B, Chacko S, Nenonen HA, Tang Y, Fahey JW, Derry JMJ, Wollheim CB, Wierup N, Haymond MW, Friend SH, Mulder H, Rosengren AH. Sulforaphane reduces hepatic glucose production and improves glucose control in patients with type 2 diabetes. Sci Transl Med. 2017 Jun 14;9(394):eaah4477. doi: 10.1126/scitranslmed.aah4477.

  PMID: 28615356 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anders Rosengren

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 15, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share