Health TrialsbyHealthPanel

Evaluating Metabolic Health in Individuals With Extreme Obesity

ConditionBMI>40
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPennington Biomedical Research Center

About this trial

This research will evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) in 10 individuals with a BMI ≥60 kgm2 using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition. Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will be recruited from Baton Rouge, Louisiana. Exclusion criteria include major organ failure, uncontrolled endocrine disease, severe psychiatric illness, pregnancy, and inability to comply with study procedures. The total duration of participation for each individual is estimated at approximately 10 days. If qualified, participants (BMI≥60 kg/m2; n=10) will complete one outpatient visit and one inpatient visit with 36hr metabolic chamber testing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female

Between 18 - 80 years of age

BMI ≥60 kg/m2

Willing to consume pre-prepared meals

Disqualifiers

Diabetic eye disease requiring laser treatment

Diabetic nerve disease associated with foot ulcers or amputations

Diabetic vascular disease associated with gangrene or amputation

Diabetic kidney disease accompanied by a creatinine greater than 2.0 mg/dL

Trial population

The population for this study is individuals aged 18 to 80 years old who have a BMI greater than or equal to 60 kg/m2 who are willing to consume pre-prepared meals and are willing to have biospecimens and images stored for future use. The reason for seeking to evaluate this specific population is because individuals with extreme obesity possess high surgical and comorbidity risks, but there is a very small amount of research conducted in these individuals.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • High-fat test meal

    Other intervention

    At Visit 2-D1, subjects will enter the chamber at approximately 17:30 and exit the following morning at 07:00. Energy expenditure, respiratory exchange ratio (RER), and 12-h oxidation of CHO, fat, and protein will be calculated per standard PBRC protocols. While in the chamber, participants will collect all their urine for measurement of urinary nitrogen. Subjects will be served one high-fat meal while they are in the chamber (40% of the daily energy requirements).

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Metabolic Flexibility1 intervention

Trial outcomes

Primary outcomes

1

24-hour Energy Expenditure

24-hour energy expenditure will be assessed from participants spending 23 hours in a metabolic chamber.

Time frame
Day 9
2

24-hour Fat Oxidation

This will be collected from the 23-hour chamber stay during Visit 2, Day 2. Specifically, this represents the total grams of fat oxidized over the 23-hour stay, calculated from indirect calorimetry stoichiometry.

Time frame
Day 9
3

Basal Energy Expenditure

This represents the amount of energy expended under strict basal conditions: post-absorptive (typically 10-12h fasted), thermoneutral, fully awake but supine and motionless, no recent physical activity. This will be collected from the 23-hour metabolic chamber stay.

Time frame
Day 9
4

Resting Energy Expenditure

This is the energy expended at rest but under less stringent conditions than basal: seated or supine, awake, post-absorptive but with less rigor about prior activity, temperature, and emotional state. This will be collected from the 23-hour metabolic chamber stay.

Time frame
Day 9

Secondary outcomes

1

Time to Food Quotient

This is the amount of minutes from meal ingestion until RER first reaches (or crosses) the meal's FQ. This represents the speed of the switch of fuel oxidation rather than its endpoint. A flexible system gets there quickly; an inflexible one takes hours or never arrives.

Time frame
Day 8
2

Respiratory Exchange Ratio: Food Quotient Ratio

This is the measured respiratory exchange ratio divided by the meal's food quotient (the theoretical RER if the meal were fully oxidized as ingested). A ratio of 1.0 means whole-body substrate oxidation has fully matched the macronutrient composition of what was just eaten; \<1.0 means oxidation is lagging behind intake (fat-dominant fuel selection persisting after a mixed or high-carb meal); \>1.0 means net lipogenesis or carryover carb oxidation. The FQ of the high-fat test meal will be used.

Time frame
Day 8
3

ΔRespiratory Exchange Ratio Nadir

This represents the drop from a reference RER (typically pre-meal fasting baseline, sometimes overnight minimum) to the lowest RER value observed. In a high-fat meal challenge this captures the magnitude of the fat-oxidation excursion: how far down the RER pushes when the meal is fat-dominant.

Time frame
Day 8
4

Post-meal Respiratory Exchange Ratio Slope

This represents the rate of RER change in the early postprandial window, usually fit as a linear slope over the first 30-90 minutes after ingestion. A steep slope would mean a rapid switch (metabolically flexible) and a shallow slope would indicate impaired metabolic flexibility.

Time frame
Day 8

Other outcomes

1

Skeletal Muscle Mass

Skeletal muscle mass will be measured using D3-creatine dilution. Participants will be administered a 60 mg capsule with D3-creatine during Visit 1. Spot urine specimens will be collected between 120 hours (5 days) and 144 hours (6 days) after administration of the D3-creatine dose.

Time frame
Day 1 to Day 5
2

Fat-free Mass

Fat-free mass will be quantified by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.

Time frame
Day 1
3

Fat Mass

Fat mass will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.

Time frame
Day 1
4

Body Fat Percentage

Body fat percentage will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.

Time frame
Day 1

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

Source ClinicalTrials.gov

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