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Sponsored by: |
McGill University |
Information provided by: | McGill University |
ClinicalTrials.gov Identifier: | NCT00608400 |
The parathyroid gland and its hormone have a major impact on the endocrine control of bone metabolism and mineralization and parathyroid hormone (PTH) has been identified in some epidemiological reports to relate adversely to mortality. Previously, the applicant has demonstrated in two models that dietary cis-9, trans-11 conjugated linoleic acid (CLA) reduces PTH by over 30% in as little as 4 weeks in male rats without adversely affecting bone density. Both bioactive PTH and intact PTH assays have been used and both are reduced by CLA. In one rat model, rats had normal PTH and a sub-group had high PTH due to chronic renal disease. In the second study, the rats were healthy young males and females. Regardless of the model and health state, PTH was reduced 30 to 40% by CLA. Of interest, other isoforms of CLA such as trans-10, cis-12 CLA do not alone result in reduced PTH. The selected CLA isomer proven to reduce PTH, cis-9, trans 11 CLA, is common to food products such as milk fat and beef and is thus more physiologically relevant to the human diet. The global objective of this study is to, for the first time; assess the effects of CLA on PTH in humans, specifically men.
Healthy men 40 years of age are selected since bone mass will have reached a peak by this age. Beginning with healthy relatively young men is important versus aging or ill individuals since the effect of CLA on PTH has not been examined and aging and illness might confound the results.
Subjects will be recruited using posters and local newspaper advertisements from the general population. Men (n=30/group) with healthy weights will be randomized to receive 0, 1.5 or 3 g CLA/d for a period of 4 months. At baseline, body weight will be assessed along with whole body bone, lean and fat mass using dual energy x-ray absorptiometry (DXA). Regional bone mass (lumbar spine, total hip, femoral neck) will also be examined using DXA. A blood sample will be taken in the fasted state between 9:00 and 10:00 to examine PTH, ionized Ca, and biomarkers of bone metabolism. After each 1 month on the study, the measurements will be repeated until end of study.
Dietary intake will be monitored along with a survey for possible mild side-effects such as gastrointestinal discomfort. Data will be examined using a mixed model for random (age, weight, vitamin D status) and fixed effects (diet, time) with post-hoc comparisons using Bonferroni correction.
Condition | Intervention | Phase |
Healthy |
Dietary Supplement: Clarinol CLA |
Phase I |
MedlinePlus related topics: | Dietary Supplements |
Drug Information available for: | Parathyroid |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Dietary Cis-9, Trans-11 Conjugated Linoleic Acid Reduce Parathyroid Hormone in Men? |
Estimated Enrollment: | 90 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
CLA 1.5 g/d
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Dietary Supplement: Clarinol CLA
1.5 or 3.0 g/d for 4 months, capsule form
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2: Experimental
CLA 3.0 g/d
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Dietary Supplement: Clarinol CLA
1.5 or 3.0 g/d for 4 months, capsule form
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3: Placebo Comparator |
Dietary Supplement: Clarinol CLA
1.5 or 3.0 g/d for 4 months, capsule form
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Show Detailed Description |
Ages Eligible for Study: | 40 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The sample size will be 90 healthy men (n=30/group) based on the following inclusion criteria:
Canada, Quebec | |||||
Mary Emily Clinical Nutrition Research Unit | |||||
Sainte Anne de Bellevue, Quebec, Canada, H9X 3V9 |
McGill University |
Principal Investigator: | Hope A Weiler, PhD | McGill University |
Responsible Party: | McGill University ( Dr. Hope Weiler, Associate professor ) |
Study ID Numbers: | HW-08-02, McGill University |
First Received: | January 23, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00608400 |
Health Authority: | Canada: Health Canada |
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