Effects of increasing calorie intake on energy expenditure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how varying caloric intake and macronutrient composition in diets affect diet-induced thermogenesis (DIT) and overall energy expenditure in healthy adults. Participants aged 18 to 60 will stay in a clinic for about 35 days, consuming provided meals that include different dietary compositions. The study will measure energy expenditure using a whole-room indirect calorimeter, assessing responses to fasting and various levels of caloric intake. The goal is to understand the relationship between calorie consumption and energy expenditure, particularly in relation to individual metabolic responses.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• NIDDK, Phoenix
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Tomas Cabeza De Baca, Ph.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Office of Participant Recruitment (NIDDK
• Email: niddkphxcontact@mail.nih.gov
• Phone: (602) 200-5315

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.