Trial Outcomes & Findings for Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy (NCT NCT02690168)

NCT ID: NCT02690168

Last Updated: 2021-07-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 6 participants
• Primary outcome timeframe: 80 hours
• Results posted on: 2021-07-19

Participant Flow

Participant milestones

Measure	Fasting 72 hour fasting
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Collected data from one participant were not considered valid due to an equipment malfunction

Baseline characteristics by cohort

Measure	Healthy Men n=6 Participants Fasting: 72 hour fasting
Age, Continuous	28.7 years STANDARD_DEVIATION 2.4 • n=6 Participants
Sex: Female, Male Female	0 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	3 Participants n=6 Participants
Race (NIH/OMB) White	3 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Weight	76.1 kg STANDARD_DEVIATION 13.7 • n=6 Participants
Body Mass Index	23.5 kg/m^2 STANDARD_DEVIATION 2.7 • n=6 Participants
Fasting glucose	85.1 mg/dL STANDARD_DEVIATION 6.9 • n=6 Participants
% body fat	17.6 % body fat STANDARD_DEVIATION 7.3 • n=6 Participants
Percent enrichment of bicarbonate	53.5 % enrichment STANDARD_DEVIATION 8.3 • n=5 Participants • Collected data from one participant were not considered valid due to an equipment malfunction
Cerebral Metabolic Rate of Acetate Ascertained Through Mathematical Modeling of MRS Data	59 micromol/g/min STANDARD_DEVIATION 20.8 • n=5 Participants • Collected data from one participant were not considered valid due to an equipment malfunction
Astroglial tricarboxylic acid cycle rate ascertained through mathematical modeling of MRS data	0.5 micromol/g/min STANDARD_DEVIATION 0.2 • n=5 Participants • Collected data from one participant were not considered valid due to an equipment malfunction
Leptin	7.2 ng/mL STANDARD_DEVIATION 5.9 • n=3 Participants • parameter could only be measured in 3 subject due to lack of collected blood volume

PRIMARY outcome

Timeframe: 80 hours

Population: Collected data from one participant were not considered valid due to an equipment malfunction

Outcome measures

Measure	Healthy Men n=5 Participants Fasting: 72 hour fasting
Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS)	61.9 % enrichment Standard Deviation 3.8

SECONDARY outcome

Timeframe: 80 hours

Population: Collected data from one participant were not considered valid due to an equipment malfunction

Outcome measures

Measure	Healthy Men n=5 Participants Fasting: 72 hour fasting
Cerebral Metabolic Rate of Acetate Ascertained Through Mathematical Modeling of MRS Data	71 micromol/g/min Standard Deviation 15.0

SECONDARY outcome

Timeframe: 80 hours

Population: Collected data from one participant were not considered valid due to an equipment malfunction

Outcome measures

Measure	Healthy Men n=5 Participants Fasting: 72 hour fasting
Astroglial TCA Cycle Rate Ascertained Through Mathematical Modeling of MRS Data	0.4 micromol/g/min Standard Deviation 0.2

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Healthy Men n=6 Participants Fasting: 72 hour fasting
Glucose Level	71 mg/dL Standard Deviation 4.9

SECONDARY outcome

Timeframe: 72 hours

Population: Data from 3 participants was not available due to lack of blood volume during collections

Outcome measures

Measure	Healthy Men n=3 Participants Fasting: 72 hour fasting
Change in Leptin Levels	5.2 ng/mL Standard Deviation 1.2

Adverse Events

Fasting

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fasting n=6 participants at risk 72 hour fasting
Musculoskeletal and connective tissue disorders Achy legs	16.7% 1/6 • Number of events 1 • 4 days
Gastrointestinal disorders vomiting	16.7% 1/6 • Number of events 1 • 4 days
Nervous system disorders Headache	50.0% 3/6 • Number of events 3 • 4 days
Respiratory, thoracic and mediastinal disorders sinus congestion	16.7% 1/6 • Number of events 1 • 4 days
Nervous system disorders insomnia	16.7% 1/6 • Number of events 1 • 4 days

Additional Information

Dr. David McDougal

Pennington Biomedical Research Center

Phone: 2257630278

Email: DAVID.MCDOUGAL@PBRC.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place