OverweightNCT04061369
Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
A study testing Low fat meal, Moderate fat meal and High fat meal in people with Overweight and Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Body Weight
- What is being tested?
- Low fat meal, Moderate fat meal and High fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index 18.5 - 39.9 kg/m2
Who cannot join
- BMI < 18.5 or > 40 kg/m2
- Presence of untreated or uncontrolled metabolic diseases
- Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)
- Presence of Crohn's disease, irritable bowel syndrome, or colitis
- Previous gallbladder removal
- Presence of cancer or other serious chronic disease
Show all 12Show fewer
- Implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator
- Presence of a large amount of metal in the body such as a hip implant
- Current use of tobacco in any form
- Claustrophobia
- Dietary restrictions that would interfere with consuming study meals
- Pregnant or nursing within the last 6 months, or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.
Read the detailed description
The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.
- Conditions
- Overweight, Obesity, Body Weight
- Being tested
- Low fat meal, Moderate fat meal, High fat meal, High fat liquid meal
- Keywords
- thermic effect of feeding, thermogenesis, calorimeter, fuel utilization
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat mealOther
Meal consisting of conventional foods that is low (20% of energy) in fat calories.
Moderate fat mealOther
Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
High fat mealOther
Meal consisting of conventional foods that is high (60% of energy) in fat calories.
High fat liquid mealOther
Liquid meal that is high (60% of energy) in fat calories.
| Study group | Role | What they receive |
|---|---|---|
| Meal 1 | Experimental | Meal consisting of conventional foods that is low (20% of energy) in fat calories. Receives: Other: Low fat meal |
| Meal 2 | Experimental | Meal consisting of conventional foods that is moderate (40% of energy) in fat calories. Receives: Other: Moderate fat meal |
| Meal 3 | Experimental | Meal consisting of conventional foods that is high (60% of energy) in fat calories. Receives: Other: High fat meal |
| Meal 4 | Experimental | A liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories. Receives: Other: High fat liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline level and change in rate of oxygen consumption
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Measured: Measured continuously from baseline up to 600 minutes post-meal
Baseline level and change in rate of carbon dioxide production
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Measured: Measured continuously from baseline up to 600 minutes post-meal
Baseline level and change in respiratory exchange ratio (RER)
RER is expressed as the ratio of VCO2 to VO2
Measured: Measured continuously from baseline up to 600 minutes post-meal
Baseline level and change in urinary nitrogen excretion
Urinary nitrogen measured via combustion and gas analysis in mg
Measured: Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Secondary outcomes (20)
Body weight
measured in kg
Measured: Baseline
Body fat
Measured in kg using multi frequency bioimpedance
Measured: Baseline
Lean body mass
Measured in kg using multi frequency bioimpedance
Measured: Baseline
Total body water
Measured in kg using multi frequency bioimpedance
Measured: Baseline
Waist circumference
measured in cm
Measured: Baseline
Hip circumference
measured in cm
Measured: Baseline
Blood pressure
Both systolic and diastolic pressure measured in mmHg using automated instrument
Measured: Baseline
Heart rate
measured in beats per minute using automated instrument
Measured: Baseline
Body temperature
measured in centigrade
Measured: Baseline
General health and well-being
The SF-36 Short form general health and well-being questionnaire measured once. The survey has eight scales; physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. All 36 items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Items in the same scale are averaged together to create the 8 scale scores.
Measured: Baseline
Usual physical activity
Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Measured: Baseline
Baseline level and change in satiety
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in hunger
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in desire to eat
Self-reported feelings of the desire to eat measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in prospective consumption
Self-reported feelings of prospective consumption measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in energy expenditure
Calculated as kcal/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Measured: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in carbohydrate combustion
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Measured: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in fat combustion
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Measured: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in thermic effect of food (TEF)
Calculated as the increase in post-meal energy expenditure above baseline energy expenditure
Measured: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in heart rate
Heart rate is estimated from wrist-worn activity monitor
Measured: Expressed from baseline up to 600 minutes post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start18 Apr 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: After Covid-19 pandemic, room calorimeter not functional
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized design that includes a volunteer receiving one of four test meals.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061369
- Sponsor's protocol ID
- FL106
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
- ClinicalTrials.gov ID
- NCT04061369
- Acronym / sponsor ID
- FL106
- Conditions
- Overweight, Obesity, Body Weight
- Keywords
- thermic effect of feeding, thermogenesis, calorimeter, fuel utilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After Covid-19 pandemic, room calorimeter not functional
- Enrolment
- 7 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.
Detailed description
The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The study will be a randomized design that includes a volunteer receiving one of four test meals.
| Arm | Type | Receives |
|---|---|---|
| Meal 1 | Experimental | Other: Low fat mealMeal consisting of conventional foods that is low (20% of energy) in fat calories. |
| Meal 2 | Experimental | Other: Moderate fat mealMeal consisting of conventional foods that is moderate (40% of energy) in fat calories. |
| Meal 3 | Experimental | Other: High fat mealMeal consisting of conventional foods that is high (60% of energy) in fat calories. |
| Meal 4 | Experimental | Other: High fat liquid mealA liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index 18.5 - 39.9 kg/m2
Key exclusion criteria (12 listed)
- BMI < 18.5 or > 40 kg/m2
- Presence of untreated or uncontrolled metabolic diseases
- Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)
- Presence of Crohn's disease, irritable bowel syndrome, or colitis
- Previous gallbladder removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fat mealMeal consisting of conventional foods that is low (20% of energy) in fat calories. | Other | Meal 1 |
| Moderate fat mealMeal consisting of conventional foods that is moderate (40% of energy) in fat calories. | Other | Meal 2 |
| High fat mealMeal consisting of conventional foods that is high (60% of energy) in fat calories. | Other | Meal 3 |
| High fat liquid mealLiquid meal that is high (60% of energy) in fat calories. | Other | Meal 4 |
Primary outcome
Baseline level and change in rate of oxygen consumption
Time frame: Measured continuously from baseline up to 600 minutes post-meal
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in rate of carbon dioxide production
Time frame: Measured continuously from baseline up to 600 minutes post-meal
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in respiratory exchange ratio (RER)
Time frame: Measured continuously from baseline up to 600 minutes post-meal
RER is expressed as the ratio of VCO2 to VO2
Baseline level and change in urinary nitrogen excretion
Time frame: Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Urinary nitrogen measured via combustion and gas analysis in mg
20 secondary outcomes
Body weight
Time frame: Baseline
Body fat
Time frame: Baseline
Lean body mass
Time frame: Baseline
Total body water
Time frame: Baseline
Waist circumference
Time frame: Baseline
Hip circumference
Time frame: Baseline
Blood pressure
Time frame: Baseline
Heart rate
Time frame: Baseline
Body temperature
Time frame: Baseline
General health and well-being
Time frame: Baseline
Usual physical activity
Time frame: Baseline
Baseline level and change in satiety
Time frame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in hunger
Time frame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in desire to eat
Time frame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in prospective consumption
Time frame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Baseline level and change in energy expenditure
Time frame: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in carbohydrate combustion
Time frame: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in fat combustion
Time frame: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in thermic effect of food (TEF)
Time frame: Expressed from baseline up to 600 minutes post-meal
Baseline level and change in heart rate
Time frame: Expressed from baseline up to 600 minutes post-meal
Results and safety
The study was stopped early (reason given: After Covid-19 pandemic, room calorimeter not functional). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat meal, Moderate fat meal and High fat meal in people with Overweight and Obesity, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After Covid-19 pandemic, room calorimeter not functional). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline level and change in rate of oxygen consumption (time frame: Measured continuously from baseline up to 600 minutes post-meal). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.