Stable Isotopes- Adults With Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-59
SponsorUniversity of Illinois at Urbana-Champaign
About this trial
In a crossover design, 8 participants will receive caloric drinks containing stable isotopes. In one arm of the study, participants will consume 6 hourly drinks containing two stable isotopes. Repeated blood, breath, urine, and muscle biopsies will be taken. In the second arm, participants will consume 1 drink containing 75g glucose, labeled with two stable isotopes of glucose. Periodic blood and breath will be taken over three hours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ages 19-59
Obese >/= 30 kg/m² and >/= 102 cm for males and >/= 88 cm for females
Godin Leisure-time or exercise questionnaire <14 units
Disqualifiers
Pregnant or become pregnant
Any known food allergies
Smoker
Are physically active
Trial design
Design model
Crossover
Treatments tested in this trial
Indispensable Amino Acid Oxidation
Procedure/SurgeryParticipants will ingest six hourly meals designed to provide 50% of the daily intake of 1.1 g·kgLBM. Additional energy (1.5x daily resting metabolic rate), carbohydrate (55%), and fat (35%) will be provided in beverages and protein-free cookies (for palatability). The first drink will contain priming doses of NaH13CO2 (0.176 mg·kg-1), \[13C\]phenylalanine (1.86 mg·kg-1), \[2H5\]phenylalanine (0.34 mg·kg-1) with all subsequent drinks containing 1.2 mg·kg-1 \[13C\]phenylalanine and 0.51 mg·kg-1 \[2H5\]phenylalanine.
Stable Isotope Oral Glucose Tolerance Test
Procedure/SurgeryParticipants will consume a 75g glucose drink dissolved in 250 ml of water enriched with \[6,6\_2H2\]glucose and \[13C6\]glucose.
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: IAAOExperimental treatment 1 intervention
Group B: SIOGTTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Define obesity-related whole body protein efficiency based of the IAAO method
Amino Acid Oxidation of phenylalanine will be measured using the IAAO method by periodic ingestion of amino acid mixture. Trials will start at \~7:00 am (-30 minutes) with a total duration of 6.5 hours (390 minutes) Measurements of breath (-30, 0, 120, 240, 270, 300, 330 and 360 minutes), Urine (-30, 0, 240, 300, and 360 minutes), muscle biopsy (-30 and 360 minutes) and blood (-30, 0, 30, 60, 90,120, 180, 240, 300, and 360 minutes) will be used to determine the whole body efficiency of protein in obese populations.
Time frame
0 - 6 hours observational period ingesting six hourly meals, within 1 week of preliminary testing. Baseline measures taken at --30 minutes.2
Assessment of oral glucose tolerance based on a dual tracer technique
Measure glucose kinetics via \[13C\] and D5 Glucose over 3 hours to determine glucose tolerance. Trials will start at \~7:00 am (-10 minutes) and last \~ 3 hours. (190 minutes)
Time frame
0- 3 hour observational period. Within 1 week of the prospective arm. Baseline taken at -30 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov