Overweight, Obesity, Body Weight
Conditions
Keywords
thermic effect of feeding, thermogenesis, calorimeter, fuel utilization
Brief 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.
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.
Interventions
OTHERLow fat meal
Meal consisting of conventional foods that is low (20% of energy) in fat calories.
OTHERModerate fat meal
Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
OTHERHigh fat meal
Meal consisting of conventional foods that is high (60% of energy) in fat calories.
OTHERHigh fat liquid meal
Liquid meal that is high (60% of energy) in fat calories.
Sponsors
USDA, Western Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.
Intervention model description
The study will be a randomized design that includes a volunteer receiving one of four test meals.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index 18.5 - 39.9 kg/m2
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline level and change in rate of oxygen consumption | 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 | 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) | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline | measured in cm |
| Hip circumference | Baseline | measured in cm |
| Blood pressure | Baseline | Both systolic and diastolic pressure measured in mmHg using automated instrument |
| Heart rate | Baseline | measured in beats per minute using automated instrument |
| Body temperature | Baseline | measured in centigrade |
| General health and well-being | Baseline | 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. |
| Usual physical activity | Baseline | Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity. |
| Baseline level and change in satiety | Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal | 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. |
| Body weight | Baseline | measured in kg |
| Baseline level and change in desire to eat | Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal | 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. |
| Baseline level and change in prospective consumption | Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal | 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. |
| Baseline level and change in energy expenditure | Expressed from baseline up to 600 minutes post-meal | Calculated as kcal/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min) |
| Baseline level and change in carbohydrate combustion | Expressed from baseline up to 600 minutes post-meal | Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min) |
| Baseline level and change in fat combustion | Expressed from baseline up to 600 minutes post-meal | Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min) |
| Baseline level and change in thermic effect of food (TEF) | Expressed from baseline up to 600 minutes post-meal | Calculated as the increase in post-meal energy expenditure above baseline energy expenditure |
| Baseline level and change in heart rate | Expressed from baseline up to 600 minutes post-meal | Heart rate is estimated from wrist-worn activity monitor |
| Baseline level and change in hunger | Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal | 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. |
| Body fat | Baseline | Measured in kg using multi frequency bioimpedance |
| Lean body mass | Baseline | Measured in kg using multi frequency bioimpedance |
| Total body water | Baseline | Measured in kg using multi frequency bioimpedance |
Countries
United States
Outcome results
None listed