Single Oral Dose of BeneFlax to Healthy Young and Older Adults (SOD)

University of Saskatchewan

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Diabetes Mellitus, Type 2

Treatments: Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01531569

NHPD - 174041

Details and patient eligibility

About

This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.

It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults: 18-45 and 60-80 years of age

Exclusion criteria

• Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
• Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
• Individuals who smoke
• Individuals who have experienced diarrhea in the last three months
• Individuals who have taken oral antibiotics in the last three months
• Individuals who are currently taking warfarin or any of its derivatives
• Individuals with low haemoglobin (<121g/L for women and <137g/L for men)
• Individuals with BMI under 19 or over 28
• Pregnant or lactating women
• Women with child bearing potential not using contraceptives
• Current diagnosis of a bleeding disorder or at risk of bleeding
• Individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
• Individuals with diabetes mellitus
• Individuals currently taking a flax seed supplement
• Individuals with an allergy to flax seed
• Individuals who have donated blood or lost > 450 mL of blood within 56 days of study duration
• Individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial

Trial design

22 participants in 1 patient group

BeneFlax

Experimental group

Description:

BeneFlax given as a single oral dose to assess pharmacokinetics

Treatment:

Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)