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混合膳食测试的变异性：固定热量与根据能量需求调整热量剂量

2026年9月18日 更新者：National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Background:

Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.

Objective:

To learn how fixed vs adjusted meals affect blood glucose levels in healthy people.

Eligibility:

Healthy people aged 18 years or older.

Design:

Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.

Participants will have baseline tests:

Their height, weight, and waist size will be measured.

They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.

They will have a body scan.

Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:

Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.

MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Study Description:

This study will be an outpatient study completed in 3-4 separate visits. We will compare two methods of dosing (fixed and adjusted) a mixed meal tolerance test (MMTT) to determine which results in greater physiological variability in hormone response. Ultimately, the goal is to determine which method of dosing is more appropriate in a research setting.

Objectives:

Primary Objective:

To determine whether an adjusted energy dose MMTT or a fixed dosed meal will result in greater variability in glucose area under the curve (AUC) within the same participants across a range of BMIs.

Secondary Objectives:

To determine whether baseline body composition, blood parameters (lipids, hormones, etc), and resting metabolic rate are associated with MMTT responses and whether this association is moderated by MMTT condition (fixed vs. adjusted).

Endpoints:

Primary Endpoint: Glucose area under the curve (AUC)

Secondary Endpoints: Area under the curve (AUC), incremental area under the curve (iAUC), value and timing of the absolute maximum (peak), value and timing of the inflection point after the absolute maximum value, value and timing of the maximum rate of incline, value and timing of the maximum rate of decline, total number of critical points with body composition, blood parameters, and resting metabolic rate as predictors.

研究类型

介入性

注册 (估计的)

79

阶段

  • 不适用

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。

学习联系方式

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85014
        • 招聘中
        • NIDDK, Phoenix
        • 接触：

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 99年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated informed consent form.
  • Agreement to adhere to Lifestyle Considerations throughout study duration.
  • Males and females; Age >= 18years
  • Healthy, as determined by medical history, physical examination, and laboratory tests.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

  • Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism.
  • Fasting plasma glucose >= 126 mg/dL
  • Type I or Type II Diabetes Mellitus by self-report.
  • Hematologic disorders including significant anemia (male hemoglobin < 13.0 g/dL or female hemoglobin < 11.0 g/dL)
  • Current pregnancy, pregnancy within the past 6 months or currently lactating
  • History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report
  • Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults.
  • Participants who report taking large doses of acetaminophen (> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study.
  • Inability to consume provided food based on a food allergy or intolerance.
  • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.
  • Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator s and/or team s opinion, jeopardizes the safety of the participant or others or would interfere with adherence to the protocol (such as claustrophobia).

Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.

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：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：1

Fixed Mixed Meal Test
其他：Fixed Mixed Meal Test

a FIXED dose meal that will be 900 kcal of a liquid meal
有源比较器：2

Adjusted Mixed Meal Test
其他：Adjusted Mixed Meal Test

a body weight ADJUSTED dose liquid meal.

(30% of total daily energy requirements)

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
To determine whether an adjusted energy dose MMTTor a fixed dosed meal will result in greater variability in glucose area under the curve (AUC) within the same participants across a range of BMIs.
大体时间：Baseline, Visit 3/4

Glucose AUC associated with MMTT conditions (fixed vs. adjusted).
Baseline, Visit 3/4

次要结果测量

结果测量
措施说明
大体时间
Body Composition
大体时间：Baseline, Visit 3/4

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).
Baseline, Visit 3/4
Resting Metabolic Rate
大体时间：Baseline, Visit 3/4

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).
Baseline, Visit 3/4
Lipids
大体时间：Baseline, Visit 3/4

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).
Baseline, Visit 3/4

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。

赞助

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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。

有用的网址

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 (实际的)

2024年8月23日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2024年1月24日

首先提交符合 QC 标准的

2024年1月24日

首次发布 (实际的)

2024年1月25日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月16日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 10001707
  • 001707-DK

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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