microRNA Testing for Identification of Personalized Weight Management

NCT04217850 | Terminated

• 1 other identifier: EN20014
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Weight Loss

Outcome Measures

Primary Outcomes (6)

• micro RNA 140

  Venous blood concentrations (M) of micro RNA 140 will be measured using our sensor.

  Change across weeks 0, 6, 13

• micro RNA 935

  Venous blood concentrations (M) of micro RNA 935 will be measured using our sensor.

  Change across weeks 0, 6, 13

• Body Composition

  Change in body composition (% fat) derived from dual x-ray absorptiometry

  Change across weeks 0, 6, 13

• Lean body mass

  Change in lean body mass (kg) derived from dual x-ray absorptiometry

  Change across weeks 0, 6, 13

• Fat mass

  Change in fat mass (kg) derived from dual x-ray absorptiometry

  Change across weeks 0, 6, 13

• Body mass

  Change in body mass (kg) derived from scale

  Change across weeks 0, 6, 13

Secondary Outcomes (5)

• High-density lipoprotein

  Change across weeks 0, 6, 13

• Total cholesterol

  Change across weeks 0, 6, 13

• Triglycerides

  Change across weeks 0, 6, 13

• Low-density lipoprotein (calculated)

  Change across weeks 0, 6, 13

• Very low-density lipoprotein (calculated)

  Change across weeks 0, 6, 13

Study Arms (1)

500 kcal Energy Deficit

EXPERIMENTAL

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; Other: Aerobic Exercise

Interventions

250 kcal Dietary Energy Restriction OTHER

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).

500 kcal Energy Deficit

Aerobic Exercise OTHER

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.

500 kcal Energy Deficit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Dakota State University: lead

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: January 13, 2020
• Primary Completion: May 4, 2020
• Study Completion: June 30, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)