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开发膳食摄入量的生物标志物

Background:

- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake.

Objectives:

- To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda).

Eligibility:

- Healthy, nondiabetic men between 18 and 65 years of age.

Design:

  • This study involves an initial screening visit and a 12-13 week inpatient dietary study period.
  • Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes.
  • After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests.
  • Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism.
  • Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period.
  • At the end of the 12-week study diet period, participants will provide additional hair, blood, and fat tissue samples, and will have a second metabolism assessment in the metabolic chamber.

研究概览

详细说明

Studies of health and nutrition use a variety of tools to determine what people eat from day to day. Unfortunately, most of the methods used are not accurate for a variety of reasons and do not provide solid information on which to base health recommendations or public policy. In general, when people are asked to keep track of what they eat or recall what they have eaten in the past, they make mistakes in estimating both amounts and specifics of what was eaten. New tools that can help determine if people are accurately remembering what they ate are desperately needed.

Biomarkers are things that can be measured (in urine, blood, hair, etc.) which are related to the intake of a particular food in a consistent way and may therefore be more accurate than a food record. One set of biomarkers that may be used are naturally occurring (present in all foods) stable isotopes of carbon and nitrogen to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. These isotopes can be measured in blood samples and hair.

The aim of this study is to validate the use of stable isotope biomarkers as representative of specific dietary intake patterns (meat/fish/soda). This study will be an inpatient study in which highly specific diets will be fed to volunteers for ~12 weeks and stable isotopes will be measured in blood and hair. The ultimate goal is to develop biomarkers to be used to validate food intake patterns in outpatient clinical and epidemiological studies.

研究类型

介入性

注册 (实际的)

59

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Arizona
      • Phoenix、Arizona、美国、85014
        • NIDDK, Phoenix

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

  • INCLUSION CRITERIA:
  • Body mass index less than or equal to 35 kg/m(2) to minimize the impact of body size on isotope measurements.
  • Males 18-65 years old will be recruited for this study. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.

Healthy, as determined by medical history, physical examination, and laboratory tests.

EXCLUSION CRITERIA:

  • Current smoking
  • Female sex
  • Baldness or hair less than 2 cm in length
  • Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized.
  • Type 2 diabetes (according to the World Health Organization diagnostic criteria)
  • Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo- and hyperthyroidism)
  • Chronic pulmonary disorders, including chronic obstructive pulmonary disease, that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry).
  • Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease)
  • Hypertension (blood pressure measurement higher than 140/90 mm Hg on two or more occasions or use of anti-hypertensive medications)
  • Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study
  • Presence of a pacemaker or other implantable devices
  • Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 x normal)
  • Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or greater than 100mg/dl of protein based on urine dipstick)
  • Central nervous system disease (cerebrovascular accidents, dementia, and neurodegenerative disorders)
  • Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
  • Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana)
  • Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder
  • Weight change of plus or minus 5% in the last 3 months

Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study.

Non-English speaking subjects as a population will be excluded from participation in this protocol. One of the secondary hypotheses of the protocol relates to a battery of psychological questionnaires and performances tests which are administered to the volunteers at the beginning and end of the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore we will restrict enrollment to English speaking subjects only.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:1. Meat, no fish or soda

weight maintaining diet with meat but no fish or soda for 12 weeks

weight maintaining diet with meat but no fish or soda

实验性的:2. Meat and soda, no fish

weight maintaining diet with meat and soda but no fish for 12 weeks

weight maintaining diet with meat and soda but no fish

实验性的:4. Meat and fish and soda

weight maintaining diet with meat, fish, and soda for 12 weeks

weight maintaining diet with meat, fish and soda

实验性的:5. Fish, no meat or soda

weight maintaining diet with meat, fish, and soda for 12 weeks

weight maintaining diet with fish but no meat or soda

实验性的:6. Fish and soda, no meat

weight maintaining diet with fish and soda but no meat for 12 weeks

weight maintaining diet with fish and soda but no meat

实验性的:7. No meat, fish, or soda

no fish, and no soda (vegetarian) for 12 weeks

weight maintaining diet with no meat, no fish, and no soda (vegetarian)

实验性的:8. Soda, no meart or fish

weight maintaining diet with soda but no meat or fish (vegetarian + soda) for 12 weeks

weight maintaining diet with soda but no meat or fish (vegetarian + soda)

实验性的:Meat and fish, no soda

weight maintaining diet with meat and fish but no soda for 12 weeks

weight maintaining diet with meat and fish but no soda

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in NIR
大体时间:Weeks 0, 2, 4, 6, 8, 10, 12

Change in nitrogen stable isotope rations (N15/N14)

Weeks 0, 2, 4, 6, 8, 10, 12
Change in CR
大体时间:Weeks 0, 2, 4, 6, 8, 10, 12

Change in carbon stable isotope ratios (13C/12C)

Weeks 0, 2, 4, 6, 8, 10, 12

次要结果测量

结果测量
措施说明
大体时间
OGTT
大体时间:第 0 周和第 12 周
第 0 周和第 12 周
Performance tests
大体时间:Weeks 0 and 12

Iowa Card Setting Test, Stroop Color Word Test, Wisconsin Card Sorting Test, Go/No Go Task

Weeks 0 and 12
Lipid panel
大体时间:Weeks 0 and 12

LDL, HDL, Triglycerides and Total Cholesterol

Weeks 0 and 12
Respiratory quotient (RQ)
大体时间:Weeks 0 and 12

Ratio of the volume of carbon dioxide (CO2) produced to the volume of oxygen (O2) used, or VCO2/VO2

Weeks 0 and 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Susanne M Votruba, Ph.D.、National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月24日

初级完成 (实际的)

2020年3月31日

研究完成 (实际的)

2020年3月31日

研究注册日期

首次提交

2010年11月6日

首先提交符合 QC 标准的

2010年11月6日

首次发布 (估计的)

2010年11月9日

研究记录更新

最后更新发布 (实际的)

2026年10月8日

上次提交的符合 QC 标准的更新

2026年10月7日

最后验证

2026年3月16日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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