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Soda Intake Biomarkers in Healthy Diets
Study Summary
This trial is testing if stable isotopes can help assess what people eat. Healthy adults ages 18-65 will stay at the NIH for 13 weeks, eating either a balanced diet or one with different percentages of carbohydrates. There will be various tests throughout to measure things like weight, body composition, and metabolism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You are in good health based on your medical history, physical exam, and lab tests.You have been diagnosed with binge eating disorder, anorexia nervosa, or bulimia nervosa.I am between 18 and 65 years old.Your body mass index (BMI) is less than or equal to 35 kg/m(2) to make sure that your body size doesn't affect the measurements we take.I am unable to understand or unwilling to sign the consent form.I do not have any unstable medical conditions like severe liver or kidney issues, active cancer (except for certain skin cancers), or serious brain disorders.I am currently using drugs like amphetamines, cocaine, or heroin.I am between 18 and 65 years old.You smoke or use tobacco products regularly and have a high level of dependence on nicotine.I have a condition like diabetes or thyroid disorder that could affect my appetite or energy.I haven't taken drugs affecting my metabolism or appetite in the last 3 months.I do not speak English.You cannot have a body mass index greater than 35 kg/m(2) because it may affect the accuracy of the measurements being taken.I have a digestive condition that could affect how my body processes food.
- Group 1: Diet with 20% of carb intake from soda
- Group 2: Diet with 50% of carb intake from soda
- Group 3: Diet with no soda
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are septuagenarians accepted to partake in this experiment?
"This study requires that participants range from 18 to 65 years old. If a patient is younger than the age of consent, there are 50 trials suitable for their condition and if they are over 65 then 376 other studies may be able to accommodate them."
What is the ultimate goal of this medical experiment?
"The primary outcome to be evaluated over baseline and week 12 of this trial is the alteration in blood carbon stable isotope ratio, measured as 13C/12C. Secondary objectives are Change in urinary sucrose/fructose over time and with varying levels of SSB intake (assessed by repeated measures two-way ANOVA), Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks (measured using a difference of 1.5 (+/-) from baseline and examined through linear mixed models for temporal change), and To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be"
What is the current participant capacity of this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this medical experiment is actively recruiting participants; it was first announced on February 23rd 2022 and has been recently modified as of November 5th 2022. Sixty patients must be enrolled from a single hospital or clinic site."
How deleterious would a diet be that consists of 20% carbohydrates from soda?
"As this is a Phase 1 trial, our team at Power has assigned Diet with 20% of carb intake from soda a score of 1 since there is limited data to support its safety or efficacy."
Are there any open positions in this trial at present?
"Data on clinicaltrials.gov verifies that this medical trial is still recruiting patients, with the initial posting taking place back in February 23rd of 2022 and a recent update occurring on November 5th of the same year."
Is it feasible for me to become involved in this clinical investigation?
"This investigation is searching for 60 volunteers aged 18–65 to partake in the dietary therapy. Eligibility requirements include: being a man or woman between those ages, exhibiting good health as attested by medical history and physical tests, and having a body mass index not exceeding 35kg/m(2)."
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