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microRNA Testing for Identification of Personalized Weight Management

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: NCT04217850
Recruitment Status : Active, not recruiting
First Posted : January 3, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
North Dakota State University

Brief Summary:
Certain blood markers are related to one's ability to successfully lose weight by diet and exercise. Currently, the laboratory tests used to measure these blood markers are expensive and time-consuming. Recently, the Electrical and Computer Engineering Department, at NDSU, invented a device that may be able to measure these blood markers much more quickly and affordably. This study is designed participate, to compare our new device to previous methods. If the new sensor is successful, it will be used as diagnostic tool to personalize weight loss strategies.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Weight Loss Other: 250 kcal Dietary Energy Restriction Other: Aerobic Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Efficacy of microRNA Testing for Identification of Personalized Weight Management Strategy in Obese and Overweight Individuals.
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 500 kcal Energy Deficit
The goal of the nutrition and exercise intervention will be to induce an energy deficit of approximately 500 kcals/day over the 12-week period in order to induce an approximate 5% weight loss in all participants.
Other: 250 kcal Dietary Energy Restriction
The nutrition intervention will be individualized and implemented as a free-living energy-restricted eating plan where energy intake will be based on a mild restriction (approx. 250 kcal/day).

Other: Aerobic Exercise
Supervised aerobic exercise will be combined with the energy restriction. Individuals will perform aerobic exercise (treadmill, cycle, or rower or combination) 4-5 days per week for 12 weeks. At each session they will expend 250 or more calories to further meet or exceed the 500 kcal energy deficit.




Primary Outcome Measures :
  1. micro RNA 140 [ Time Frame: Change across weeks 0, 6, 13 ]
    Venous blood concentrations (M) of micro RNA 140 will be measured using our sensor.

  2. micro RNA 935 [ Time Frame: Change across weeks 0, 6, 13 ]
    Venous blood concentrations (M) of micro RNA 935 will be measured using our sensor.

  3. Body Composition [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in body composition (% fat) derived from dual x-ray absorptiometry

  4. Lean body mass [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in lean body mass (kg) derived from dual x-ray absorptiometry

  5. Fat mass [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in fat mass (kg) derived from dual x-ray absorptiometry

  6. Body mass [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in body mass (kg) derived from scale


Secondary Outcome Measures :
  1. High-density lipoprotein [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in high density lipoprotein (mg/dL) from Piccolo Xpress Blood Chemistry Analyzer

  2. Total cholesterol [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in total cholesterol (mg/dL) from Piccolo Xpress Blood Chemistry Analyzer

  3. Triglycerides [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in triglycerides (mg/dL) from Piccolo Xpress Blood Chemistry Analyzer

  4. Low-density lipoprotein (calculated) [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in low-density lipoprotein (mg/dL) from Piccolo Xpress Blood Chemistry Analyzer

  5. Very low-density lipoprotein (calculated) [ Time Frame: Change across weeks 0, 6, 13 ]
    Change in very low-density lipoprotein (mg/dL) from Piccolo Xpress Blood Chemistry Analyzer



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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy
  • body mass index 25-34.9
  • able to do physical activity and exercise

Exclusion Criteria:

  • currently participating in a structured diet or excise program,
  • pregnant,
  • currently use any nicotine product
  • diagnosed neuromuscular disease
  • diabetes,
  • uncontrolled high blood pressure,
  • diagnosed cancer,
  • previously had a heart attack or other chronic heart related conditions that are not controlled with medicine
  • difficulty moving without assistive devices or walking one-quarter mile
  • are taking medications that influence muscle size (testosterone, growth hormone, etc.),
  • have had bariatric surgery
  • have a body mass greater than 350lbs,
  • fear blood, blood draws, or needles
  • adverse reaction to a blood draw in the past.

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): NCT04217850


Locations
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United States, North Dakota
North Dakota State University
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
North Dakota State University
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Responsible Party: North Dakota State University
ClinicalTrials.gov Identifier: NCT04217850    
Other Study ID Numbers: EN20014
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Signs and Symptoms
Body Weight Changes