The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 35 days
- Procedures mentioned: Urine samples, Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Design: Participants will stay in a clinic for about 35 days."
- "They will be screened with blood and urine tests and a test of their heart function."
- "They will answer questionnaires about topics including eating behavior, hunger, and stress."
- "Blood tests will be repeated."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how different diets and calorie amounts change the energy the body uses to process food and over a full day. It is for healthy adults ages 18 to 60 who have not tried to lose weight in the past 6 months. Participants stay in a clinic for about 35 days and eat only the food provided.
Background: Diet-induced thermogenesis (DIT) is the amount of energy one's body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT. Objective: To learn how different diets can change a person's DIT. Eligibility: Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months. Design: Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets. Participants will undergo multiple tests. They will be screened with blood and urine tests and a test of their heart function. During the first few days: Their waist, thigh, and neck circumference will be measured. They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body. They will be tested for diabetes. They will answer questionnaires about topics including eating behavior, hunger, and stress. Throughout the study: Their weight will be measured daily. Blood tests will be repeated. They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period. ...
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 to 60.
- Have not intentionally lost weight in the past 6 months.
Who can't join
- Diabetes; certain hormone, lung, heart, liver, kidney, or brain conditions; or high blood pressure.
- Certain long-term infections or cancer needing treatment in the past 5 years, with some exceptions. Researchers may also exclude people for other health conditions.
- Tobacco use above a very low level of dependence, signs of alcohol misuse on a screening test, or current illegal drug use. Marijuana use is allowed.
- Pregnancy, breastfeeding, irregular periods, or being near or past menopause—the time when periods stop.
- Weight of 450 pounds or more.
- Unable to speak or read English, or unable to give informed consent, meaning you understand and agree to join.
- Mental health conditions that could make joining unsafe or difficult, including fear of closed spaces, depression, or bipolar disorder.
- Use of medicines, supplements, or other treatments that change how the body uses energy, or dietary concerns that prevent eating at least 95% of the provided calories.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Male or female, aged 18-60 years old * No episodes of intentional weight loss over previous 6 months EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) * Diabetes i. Fasting glucose \>= 126 mg/dl or hba1c \>= 6.5% or ii. history of type 1 or type 2 diabetes -Endocrine disorders, such as i. History of Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism ii. TSH \<0.1 or \>= 10 uIU/mL * Pulmonary disorders i. History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment) * Cardiovascular diseases, i. Including history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease * Hypertension, i. History of diagnosis and current treatment by an outside clinician ii. or sitting blood pressure measurement, using an appropriate cuff, higher than 140/90 mmHg -Liver disease, i. including history of cirrhosis, active hepatitis B or C ii. AST or ALT \>=3 times upper limit of normal on screening labs * Renal disease i. Serum creatinine \>= 1.5 mg/dls * Abnormal kidney function (eGFR \<60 mL/min/1.73m\^2) * Central nervous system disease: i. including history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders * Cancer: i. History requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer). * Infectious disease: i. History of active tuberculosis, HIV chronic coccidiomycosis or other chronic infections * Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators * Evidence of alcohol abuse as defined by \> =8-point score on the Alcohol consumption screening AUDIT questionnaire in adults * Current use of illegal drugs such as amphetamines, cocaine, opiates, or heroin; use of marijuana is permitted. * For Females: * i. Pregnancy or lactation by history and urine pregnancy test * ii. Peri- or post-menopause by self-report or irregular menstrual cycle. * Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer). * Inability to speak or read English by self-report. * Inability to provide informed consent * History of psychological conditions including (but not limited to) claustrophobia, clinical depression, bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study * Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism * Inability to consume provided diets due to dietary concerns that will not allow them to consume \>=95% of provided calories.
Study sites (1)
AZ
- NIDDK, Phoenix · Phoenix, AZ 85004Office of Participant Recruitment-NIDDK · Study contact · 602-200-5315 · niddkphxcontact@mail.nih.govMore trials in Phoenix