Clinical trial for Obesity
Official title The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
ClinicalTrials.gov ID: NCT05545306
What this study is testing
- What it's testing
- The study aims to find out how changing the amounts of protein, fat, carbs, and total calories in a diet influences diet‑induced thermogenesis, the energy the body uses to process food.
- Who it's for
- Healthy volunteers aged 18 to 60 who have not intentionally lost weight in the past six months.
- What's involved
- Participants will live at the clinic for about 35 days, eat only study‑provided meals, and follow eight different diets. They will have regular blood and urine tests, body measurements, a body‑fat scan (DXA), and stay in a metabolic chamber nine times for 24‑hour monitoring.
- Time commitment
- The study lasts roughly 35 days with daily weight checks and multiple clinic visits for tests and chamber stays.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Male or female, aged 18-60 years old
- No episodes of intentional weight loss over previous 6 months
You likely can't join if
- 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.
- Pulmonary disorders i. History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol...
- 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.
- Renal disease i. Serum creatinine \>= 1.5 mg/dls
See the full eligibility criteria
- Male or female, aged 18-60 years old
- No episodes of intentional weight loss over previous 6 months
- 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.
- 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.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.