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OpenTrials
Completed

NCT Number: NCT01824173

Muscle Protein Metabolism in Obesity

Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese individuals. This research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The findings will help to develop appropriate interventions to improve muscle ATP turnover and metabolism in obese people.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI): lean, 19-26 kg/m2; obese, 30-40 kg/m2
  • Availability of transportation
  • Ability to sign informed consent form

Exclusion criteria

  • Medication or supplements (i.e. amino acids, protein) known to affect protein metabolism
  • Presence of acute illness
  • History of liver disease
  • Uncontrolled metabolic disease
  • ECG documented abnormalities, atrial fibrillation, history of syncope, limiting or unstable angina, or congestive heart failure
  • Chronically elevated blood pressure (systolic, >140 mmHg; diastolic, >100 mmHg)
  • Cardiac pacemaker or other medical device implanted in the body
  • Low hemoglobin or hematocrit
  • Current participation in a weight-loss regimen, including extreme dietary practices
  • Smoking
  • Use of anabolic steroids or corticosteroids (within 3 months)

Treatment and study plan

Increase in the levels of plasma amino acids

Other

Aminosyn 15%; 160 mg/kg FFM/h for 4 hours

Aerobic Exercise

Other

Moderate intensity for 45 minutes

Primary outcomes

  1. Rate of synthesis of muscle proteins (mixed muscle proteins, mitochondrial proteins, β-F1-ATPase)

    Time frame: Measured during a 9-hour infusion study

Secondary outcomes

  1. β-F1-ATPase mRNA expression; PGC-1 expression

    Time frame: Measured during a 9-hour infusion study

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Regulation of Muscle ATP Synthase Beta Subunit Metabolism in Obesity

Important dates

Study start
2012
Primary completion
2017
Study completion
2020
First posted
Apr 4, 2013
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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