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Caloric Intake Changes for Diet-Induced Thermogenesis in Obesity
N/A
Recruiting
Led By Tomas Cabeza De Baca
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 days
Awards & highlights
Study Summary
This trial is looking at how different diets can change a person's diet-induced thermogenesis.
Who is the study for?
Healthy adults aged 18-60 who haven't tried to lose weight on purpose in the last 6 months can join this study. People with heart, brain, lung diseases, diabetes, endocrine or kidney disorders, liver disease, certain cancers or infections, alcohol/drug abuse issues or pregnant/lactating women cannot participate.Check my eligibility
What is being tested?
The trial is testing how different diets affect the body's energy use after eating. Participants will stay in a clinic for about 34 days and try out eight diet variations with differing amounts of calories from carbs, proteins and fats while undergoing various tests including blood work and staying in a metabolic chamber.See study design
What are the potential side effects?
There may not be direct side effects from participating since it involves dietary changes rather than medication; however participants might experience discomfort from frequent testing procedures like blood draws and staying in a metabolic chamber.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diet Induced Thermogenesis
Secondary outcome measures
24 hour energy expenditure (24h EE)
FGF 21
Ghrelin
+3 moreTrial Design
10Treatment groups
Active Control
Group I: Set 10Active Control7 Interventions
+200% LPF -25% Fasting +200% SOF -50% +150% LPF +150% SOF
Group II: Set 4Active Control7 Interventions
Fasting -25% +200% LPF -50% +200% SOF +150% SOF +150% LPF
Group III: Set 3Active Control7 Interventions
+150% LPF Fasting +150% SOF -25% +200% SOF +200% LPF -50%
Group IV: Set 9Active Control7 Interventions
+150% SOF -25% +150% LPF +200% SOF Fasting +200% LPF -50%
Group V: Set 1Active Control7 Interventions
+150% LPF +150% SOF -50% +200% LPF +200% SOF Fasting -25%
Group VI: Set 2Active Control7 Interventions
+150% LPF +200% LPF -50% +150% SOF Fasting -25% +200% SOF
Group VII: Set 5Active Control7 Interventions
-25% +150% SOF +200% LPF +150% LPF Fasting +200% SOF -50%
Group VIII: Set 6Active Control7 Interventions
Fasting +200% LPF +200% SOF -50% +150% LPF -25% +150% SOF
Group IX: Set 7Active Control7 Interventions
-50% +200% SOF -25% +150% SOF Fasting +200% LPF +150% LPF
Group X: Set 8Active Control7 Interventions
-50% +150% SOF +200% SOF +150% LPF -25% +200% LPF Fasting
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,314,472 Total Patients Enrolled
446 Trials studying Obesity
588,818 Patients Enrolled for Obesity
Tomas Cabeza De BacaPrincipal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes with high blood sugar or a history of diabetes.I am between 18 and 60 years old.I have a history of chronic infections like TB or HIV.I do not have severe lung problems that would stop me from following the study's requirements.I haven't needed cancer treatment in the last 5 years, except for non-dangerous skin cancers or fully cured cancers.I have been diagnosed with high blood pressure and am currently being treated for it.I have a history of heart or blood vessel diseases.I have a history of Cushing's, pituitary disorders, or thyroid issues with specific TSH levels.I do not use illegal drugs, but I may use marijuana.I have a history of brain-related health issues, like strokes or dementia.My kidney function is impaired, with high creatinine or protein levels.I have liver disease, such as cirrhosis or hepatitis, or my liver tests are high.
Research Study Groups:
This trial has the following groups:- Group 1: Set 10
- Group 2: Set 4
- Group 3: Set 3
- Group 4: Set 9
- Group 5: Set 1
- Group 6: Set 2
- Group 7: Set 5
- Group 8: Set 6
- Group 9: Set 7
- Group 10: Set 8
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05545306 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program currently recruiting new participants?
"This particular trial, which was updated on November 18th, is not actively looking for participants at this time. However, there are nearly 2,000 other trials that patients may be eligible for."
Answered by AI
Can minors participate in this research study?
"The age range for potential participants in this clinical trial is 18-60 years old."
Answered by AI
How do I sign up for the clinical trial?
"Eligibility requirements for this study include being obese and aged 18-60. Up to 120 participants are needed for the clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
NIDDK, Phoenix
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I cant lose weight. I don't consider myself to have a very high calorie intake, I'm very interested in things that can affect TDEE.
PatientReceived no prior treatments
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