Effects of increasing calorie intake on energy expenditure

The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure

This study is testing how different amounts of calories and types of food affect how much energy healthy adults burn while staying in a clinic for about 35 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT05545306 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 60 who have not intentionally lost weight in the past six months.

Not a fit: Patients with diabetes or significant pulmonary or cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary strategies for managing obesity and improving metabolic health.

How similar studies have performed: Previous studies have shown varying results regarding the relationship between caloric intake and energy expenditure, making this approach both relevant and novel.

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.

Where this trial is running

Phoenix, Arizona

• 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

Conditions Obesity; Normal Physiology; Healthy Volunteers; Weight Gain; Energy Expenditure; Low Protein Overfeeding; Fasting; Natural History