Research Participant Information

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

McGillUniversity

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;
Perform a bone scan on your spine 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 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;

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 x-rays (~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.

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 McGillUniversity.

Contact

If you have any questions during or after the study, contact the study researchers or the study staff:

Principal Researcher Project CoordinatorPhD Candidate

Dr. Hope Weiler, RD, PhD Catherine Vanstone, RNJason 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 McGillUniversity, 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 theInstitutional 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: ______1 of 4

Participant’s Initials and Date______