microRNA Testing for Identification of Personalized Weight Management
microRNA Testing for Identification of Personalized Weight Management
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.
Obesity is increasing exponentially in the United States (US), and over 160 million Americans
 are either overweight or obese. A combined diet and exercise program is the most
 cost-effective alternative for weight management, but there is a considerable
 inter-individual variability in losing weight via this method, which leaves many individuals
 frustrated and unable to adhere to programs throughout the lifespan. Therefore, the inability
 to identify the individuals who will likely succeed with diet and exercise for weight
 management is a critical roadblock to treating obesity. Recent studies have shown that
 significant variability in weight loss response to diet and exercise could be attributed in
 part to individual epigenetic makeup. One potential approach for monitoring the epigenetic
 response during weight-loss interventions is small non-coding circulating RNAs, called
 microRNAs (miRNAs or miRs), in the circulating blood. Studies have shown that miR-140 and 935
 could be used as blood biomarkers to identify individuals who will succeed in managing their
 weight through diet and exercise. Moreover, during a short diet and exercise intervention,
 fluctuations of expression levels of biomarker miRNAs pre- and post-intervention have
 produced unique signature changes only in the individuals who continued the intervention for
 an extended period of time and attained a healthy body weight. Thus, if implemented early in
 a medical weight loss program it could allow for the patient to have a focused individualized
 treatment.

 A major barrier that prevents the use of miRNAs in weight loss interventions is the inability
 of accurately quantifying miR-140 and 935 levels in blood samples. To minimize the miRNA
 contamination from red-blood cell lysis, miRNA analysis must be performed within 30 minutes
 of blood draw. Current miRNA detection and quantification technologies take hours/days to
 quantify miRNAs, require bulky equipment, and are expensive. In addition, current miRNA
 detection methods do not have sufficient sensitivity, detection span and specificity for
 clinical sample analysis. To address this need, PI. Nawarathna has recently developed a
 highly sensitive disposable miRNA sensor that can quantify miRNAs in point-of-care settings
 within 15 minutes with an assay cost of $50 per test. However, the effectiveness of the
 developed miRNA sensor to accurately quantify the variations of target miRNA levels (miR-140
 and 935) pre- and post-diet and exercise intervention is unknown.

 The objective of the proposed work is to investigate the efficacy of this miRNA sensor as a
 potential diagnostic device in weight management. If successful, the impact of proposed the
 research is two-fold: first, development of a point-of-care diagnostic device (miRNA sensor)
 for providing a personalized strategy for weight management (diet and exercise or bariatric
 surgery) and second, ability to immediately expand miRNA detection to measure other factors
 that can impact overall well-being (e.g.: mental and emotional health, stress, and fatigue)
 and diseases (e.g.: cancer, cardiovascular diseases, and others). The objective of the
 proposed research will be achieved through following this specific aim:

 Aim: To investigate if the miRNA sensor is capable of identifying individuals who will
 consistently lose weight with energy restricted diet and exercise intervention.

 The proposed research will develop a pilot study with overweight individuals as participants.
 Subjects will participate in the diet and exercise intervention for 12 weeks and miRNA
 analysis will be performed at 3 time points during the intervention (pre-mid-post). We will
 then investigate the effectiveness of the sensor.

 The miRNA sensor technology, once fully developed, will be similar to a finger prick glucose
 monitor. Once commercially available, miRNA sensors can be purchased and used for diagnostic
 applications in clinics or self-testing at home or remote and rural area clinics and
 hospitals. Therefore, the outcomes will fundamentally advance how the individualized weight
 management method is selected. For this reason, this research has a positive translational
 impact on human health.
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.