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临床试验/NCT00608400
NCT00608400已完成1 期

Does Dietary Cis-9, Trans-11 Conjugated Linoleic Acid Reduce Parathyroid Hormone in Men?

McGill University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
55
试验地点
2
主要终点
Parathyroid Hormone

研究概览

简要总结

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 19-53 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.

详细描述

EXPERIMENTAL DETAILS The global objective of this study is to, for the first time; assess the effects of CLA on PTH in humans, specifically men.

Primary Objectives and Hypotheses, in healthy men 40 years of age are to determine if:

  1. Cis-9, trans-11 CLA reduces PTH;

a. it is hypothesized that CLA will reduce PTH by 30%. 2. The effect is transient; b. it is hypothesized that PTH will fall within 4 weeks of treatment and remain stable thereafter over the 4 months of study. 3. Short-term changes in bone metabolism accompany reductions in PTH following dietary intake of CLA; c. it is hypothesized that bone resorption will be reduced as indicated by resorption markers and the ratio of osteoprotegerin to RANKL.

Secondary Objective and Hypothesis is to determine if:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 53 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • The sample size will be 90 healthy men (n=30/group) based on the following inclusion criteria:
  • Healthy body weight based on body mass index (18.5 - 25 kg/m2 as per Health Canada
  • No chronic diseases
  • Normal bone mass for age (ie Z-score better than -1 where reference data available)
  • Vitamin D status within optimal range based on serum 25(OH)D (between 50 and 80 nmol/L of serum 25(OH)D with a median threshold of 75 nmol/L as set by international experts.

排除标准

  • 未提供

结局指标

主要结局

Parathyroid Hormone

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hope Weiler

Associate Professor

McGill University

研究点 (2)

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