RESEARCH PARTICIPANT INFORMATION
AND CONSENT FORM
Title of Study: Does a dietary conjugated linoleic acids glycerides supplement reduce
parathyroid hormone in men?
Protocol Number: HW-08-02
IRB Number: A00-M11-08B
Principal Investigator: Hope Weiler, RD (CDO), PhD
Co-Investigator: Dr. Gustavo Duque, MD, PhD
Study Coordinator: Catherine Vanstone RN (OIIQ), MSc.
Institution: Mary Emily Clinical Nutrition Research Unit
McGill University
Sponsor: Dairy Farmers of Canada
Introduction
The parathyroid gland and its hormone have a major impact on the endocrine
control of bone metabolism and mineralization. In some studies, high levels of
parathyroid hormone have been shown to have an adverse effect on health. Certain foods
have dietary components, which may lower parathyroid hormone and improve bone
health.
Milk contains various types of nutritious fats including one called conjugated
linoleic acid or CLA for short. This fat has been shown to lower parathyroid hormone in
animal studies. Lowering this hormone with CLA could have important impacts on
health and lead to new approaches in achieving optimal bone health.
Purpose of study
The proposed research aims to see if CLA will also reduce parathyroid hormone
in humans. Overall the results will be important in supporting human health and also
advancing our understanding of how milk plays an important role in bone health.
Study procedures
The study will be carried out in healthy 19-53 year old men for a 4 month period
to learn how much CLA is needed by humans to reduce parathyroid hormone. To
determine whether you are eligible to participate in the study a screening visit is
conducted.
Screening visit:
At the screening visit we will:
 Measure your weight and height;
 Obtain a fasting 5ml blood sample to assess your vitamin D level;
Participant Code: _________________________________________
Participant’s Initials and Date_______________________________
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Perform a bone scan on your spine and hip. This scan uses a very low dose of xrays and will allow us to see and measure your bone mineral content. The scan
only takes 3 minutes and done lying down on your back;
Complete a general health assessment.
You will be contacted a week or two later, when we receive the results, to inform you of
your eligibility for the study. To be eligible you must have:
 Healthy body weight for height;
 Vitamin D status in normal range;
 Normal bone mass for age;
 Be in good health defined as no chronic disease or condition or use of prescribed
medications known to affect parathyroid hormone;
 Not used natural health products during the month prior to starting the study or
take any natural health products during the study.
Study involvement:
If you are eligible to participate you will be given one of three treatments of CLA for a 4
month period. You will not know which treatment you are given. One treatment is a
placebo which contains no CLA, one treatment contains 1.5 g CLA and the other
treatment contains 3 g of CLA. You will be asked to take 3 capsules with your lunch and
3 capsules with your supper each day during the 4 month study period. Over the study
duration you must maintain your current dietary habits and keep your activity level and
weight bearing exercises as constant as possible. There are 5 scheduled visits to the
nutrition clinic. The first visit is called the baseline visit and the subsequent visits will be
follow-up visits after 1, 2, 3 and 4 months of treatment.
Baseline visit:
At the first study visit we will:
 Measure your weight and height;
 Obtain a fasting 15ml blood sample to assess your vitamin D, calcium, phosphate,
PTH and CLA levels, as well as, specific markers of bone metabolism and lipid
levels;
 Perform a bone scan (DXA) of your whole body, spine, forearm and hip. This
scan uses a very low dose of x-rays and will allow us to see and measure your
bone mineral content. The scans only take 5 minutes and are done lying down on
your back;
 Take your blood pressure;
 Ask you to complete a food frequency questionnaire (FFQ);
 Ask you to complete a 24-h diet recall at the visit and another one 2 weeks later
over the telephone.
Follow-up visits after 1, 2, 3 and 4 months of treatment:
At each follow-up we will:
 Measure your weight and height;
Participant Code: _________________________________________
Participant’s Initials and Date_______________________________
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Obtain a fasting 15ml blood sample to assess your vitamin D, calcium, phosphate,
PTH and CLA levels, as well as, specific markers of bone metabolism and lipid
levels;
Take your blood pressure;
Ask you to complete a 24-h recall at the visit and another one 2 weeks later over
the telephone;
Ask you to complete a health questionnaire.
At 4 month visit only:
 Perform a bone scan (DXA) of your whole body, as well as, scans of your spine,
forearm and hip.
Benefits
You may not receive direct benefit from participating in this study. The knowledge
gained through this study will help us to improve nutritional recommendations for adults.
Risks
Bone density measurement is performed by using an x-ray. However, the amount of
radiation is much less than a regular chest x-ray and equivalent to the radiation
accumulated during one normal day. The procedure has been validated for measuring
bone mass and delivers minimal radiation (8 uSv) that is lower than standard dental xrays (~60 uSv).
There are minimal risks associated with blood sampling, such as pain and bruising at the
site of needle entry.
Subject Rights: Withdrawal from the Study or Early Cessation of the Study
Participation is voluntary and you have the right to withdraw your participation in the
study at any time. You will be closely monitored for changes in your blood values. If we
find that your blood test results are abnormal, we will repeat the tests and then ask you to
stop taking the CLA supplement supplied by the study.
Costs
There will be no cost for the study measurements that you participate in.
Compensation
You will be provided the CLA supplement at no charge during the time you are enrolled
in the study. You will also be provided with $20 per visit to the clinic towards the cost of
travel. There is no cost for parking at the clinic.
Participant Code: _________________________________________
Participant’s Initials and Date_______________________________
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Confidentiality
Information gathered in this research study may be published or presented; however, your
name will not be used or revealed. Medical records that contain your identity will be
treated as confidential and maintained at the Mary Emily Clinical Research Unit in a
locked cabinet. Despite efforts to keep your personal information confidential, absolute
confidentiality cannot be guaranteed. Your personal information may be disclosed if
required by law. Organizations that may inspect and/or copy your research records for
quality assurance and data analysis include groups such as the Institutional Review Board
of the Faculty of Medicine at McGill University.
Contact
If you have any questions during or after the study, contact the study researchers or the
study staff:
Principal Researcher
Project Coordinator
PhD Candidate
Dr. Hope Weiler, RD, PhD Catherine Vanstone, RN
Jason DeGuire, MSc
(514)398-7527
(514)398-7527
(514)398-7527
(514)398-7905
For questions about your rights as a research participant, you may contact Mrs. Ilde
Lepore of the McGill University, Faculty of Medicine, Institutional Review Board at
(514) 398-8302.
Statement of Consent
I have read this consent form. I have had the opportunity to discuss this research study
with Dr. Weiler and/or the study staff. I have had my questions answered by them in a
language I understand. The risks and benefits have been explained to me. I will be
provided with a copy of this consent form after signing it. I understand that my
participation in this clinical study is voluntary and that I may choose to withdraw at any
time. I freely agree to participate in this research study.
I have been informed that information regarding my personal identity will be kept
confidential, but that confidentiality is not guaranteed. I authorize the inspection of my
research records by the Institutional Review Board of McGill University.
By signing this consent form, I have not waived any of the legal rights that I have as a
participant in a research study.
Participant’s signature: ______________________________Date:__________________
Participant’s printed name: _________________________________________________
Witness (person who obtained consent):_____________________Date: _____________
Participant Code: _________________________________________
Participant’s Initials and Date_______________________________
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