Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 44 of 750 for:    Area Under Curve AND meal

Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (METFLEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03839641
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
David McDougal, Pennington Biomedical Research Center

Brief Summary:
The overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to nadir, slope, area under the curve).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: High fat meal Other: Low fat meal Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: High Fat Meal First
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
Other: High fat meal
60% fat meal

Other: Low fat meal
20% fat meal

Experimental: High Fat Meal Second
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
Other: High fat meal
60% fat meal

Other: Low fat meal
20% fat meal




Primary Outcome Measures :
  1. change in respiratory quotient [ Time Frame: 12 hours ]
    meal stimulated change in respiratory quotient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligibility criteria include:

    • Healthy male or female
    • Ages 18-40 y
    • BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
    • Are willing to consume pre-prepared meals
    • Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study.
    • Medically cleared for participation in the study by Medical Investigator

Exclusion Criteria:

  • Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:

    • Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
    • Currently working shift work
    • Smoking or use of tobacco products within the last 3 months
    • Amenorrhea (or absence of regular monthly cycles)
    • History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
    • Average screening blood pressure >140/90 mmHg
    • Previous bariatric surgery (or other surgeries) for obesity or weight loss
    • Use of medications affecting metabolism or sleep
    • History of neurological disease
    • History of cardiovascular disease (or other chronic diseases)
    • Pregnant, planning to become pregnant, or breastfeeding
    • Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839641


Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124
Sponsors and Collaborators
Pennington Biomedical Research Center
  Study Documents (Full-Text)

Documents provided by David McDougal, Pennington Biomedical Research Center:
Study Protocol  [PDF] November 29, 2018


Layout table for additonal information
Responsible Party: David McDougal, Assistant Professor-Research, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03839641     History of Changes
Other Study ID Numbers: PBRC 2018-029
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases