Trial Outcomes & Findings for Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (NCT NCT03839641)

NCT ID: NCT03839641

Last Updated: 2021-09-17

Results Overview

12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2021-09-17

Participant Flow

Participant milestones

Measure	High-fat Meal, Washout (5-7 Days), and Low-fat Meal Arm 1 participants randomized to receive high fat meal first, and low fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal	Low-fat Meal, Washout (5-7 Days), and High-fat Meal Arm 2 participants randomized to receive low fat meal first, and high fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal
Overall Study STARTED	5	5
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	High-fat Meal, Washout (5-7 Days), and Low-fat Meal Arm 1 participants randomized to receive high fat meal first, and low fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal	Low-fat Meal, Washout (5-7 Days), and High-fat Meal Arm 2 participants randomized to receive low fat meal first, and high fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Baseline characteristics by cohort

Measure	High-fat Meal, Washout (5-7 Days), and Low-fat Meal n=4 Participants Arm 1 participants randomized to receive high fat meal first, and low fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal	Low-fat Meal, Washout (5-7 Days), and High-fat Meal n=4 Participants Arm 2 participants randomized to receive low fat meal first, and high fat meal second High fat meal: 60% fat meal Low fat meal: 20% fat meal	Total n=8 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 7.5 • n=5 Participants	27 years STANDARD_DEVIATION 5.7 • n=7 Participants	28 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
baseline respiratory exchange ratio	0.845 ratio STANDARD_DEVIATION 0.018 • n=5 Participants	0.856 ratio STANDARD_DEVIATION 0.026 • n=7 Participants	0.851 ratio STANDARD_DEVIATION 0.023 • n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

12-h mean of respiratory exchange ratio following each meal type.

measurement interval = 12h following start of meal (7pm)

The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Overnight Respiratory Exchange Ratio	0.832 ratio Standard Deviation 0.014	0.887 ratio Standard Deviation 0.017

SECONDARY outcome

Timeframe: 3 h

mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.

measurement interval = 3h (2am-5am)

The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Sleep Respiratory Exchange Ratio	0.820 ratio Standard Deviation 0.016	0.867 ratio Standard Deviation 0.034

SECONDARY outcome

Timeframe: 4 h

mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type

Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.

Baseline values were measured 1h prior to meal (5:00-5:45pm)

measurement interval of peak values= 4h (6pm-10pm)

A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Peak Increase in Respiratory Exchange Ratio	0.057 ratio Standard Deviation 0.030	0.103 ratio Standard Deviation 0.025

SECONDARY outcome

Timeframe: 12 h

mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type

Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.

Baseline values were measured 1h prior to meal (5:00-5:45pm)

measurement interval of nadir values= 12h (6pm-6am)

A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Peak Decrease in Respiratory Exchange Ratio	0.093 ratio Standard Deviation 0.031	0.025 ratio Standard Deviation 0.038

SECONDARY outcome

Timeframe: 12 h

Average time from meal to peak respiratory exchange ratio value

This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Time to Peak Respiratory Exchange Ratio	61.9 minutes Standard Deviation 13.3	100.3 minutes Standard Deviation 45.4

SECONDARY outcome

Timeframe: 12 h

Average time from meal to nadir respiratory exchange ratio value

This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Time to Nadir Respiratory Exchange Ratio	274 minutes Standard Deviation 12.8	427 minutes Standard Deviation 113

SECONDARY outcome

Timeframe: 12 h

This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.

A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.

Outcome measures

Measure	High Fat Meal n=8 Participants overnight respiratory exchange ratio following high-fat meal	Low-fat Meal n=8 Participants overnight respiratory exchange ratio following low-fat meal
Slope of Respiratory Exchange Ratio	-0.042 ratio/minute Standard Deviation 0.007	-0.028 ratio/minute Standard Deviation 0.016

Adverse Events

High-fat Meal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Low-fat Meal

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High-fat Meal n=8 participants at risk High fat meal: 60% fat meal	Low-fat Meal n=8 participants at risk Low fat meal: 20% fat meal
Musculoskeletal and connective tissue disorders muscle ache	0.00% 0/8 • From enrollment through study completion, an average of 20 days	12.5% 1/8 • Number of events 1 • From enrollment through study completion, an average of 20 days
Reproductive system and breast disorders menstrual cramps	0.00% 0/8 • From enrollment through study completion, an average of 20 days	12.5% 1/8 • Number of events 1 • From enrollment through study completion, an average of 20 days
Respiratory, thoracic and mediastinal disorders sinus congestion	12.5% 1/8 • Number of events 1 • From enrollment through study completion, an average of 20 days	0.00% 0/8 • From enrollment through study completion, an average of 20 days
Respiratory, thoracic and mediastinal disorders sore throat	12.5% 1/8 • Number of events 1 • From enrollment through study completion, an average of 20 days	0.00% 0/8 • From enrollment through study completion, an average of 20 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