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Study Summary
This trial will test if a fat- intake can help improve weight-loss maintenance after a weight-loss program.
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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Who is running the clinical trial?
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- You have a serious mental health condition, such as an eating disorder, as defined in the DSM-IV.I am between 18 and 45 years old.You have had a pacemaker or neurostimulator implanted in the past.You have a history of alcoholism or regular drug use.A person who is right-handed and has a score of ≥ + 50 on the modified Edinburgh handedness scale.You have a body mass index (BMI) above 25.0.You have trouble smelling or tasting things.I am not taking medications that make me less alert.I have worked with metals, had a metal-related injury, or undergone major surgery.I have been diagnosed with diabetes.I do not have any serious or unstable illnesses.I am okay with undergoing fMRI scans and I like milkshakes at least a little.I have had a severe head injury with unconsciousness.You are currently pregnant.You have a known allergy to certain foods.
- Group 1: RiduZone (90% Oleoylethanolamide (OEA))
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many participants is this trial recruiting?
"Affirmative, the clinicaltrials.gov records confirm that the trial is actively looking for potential participants; it was initially posted on April 6th 2021 and last modified on November 18th 2022. A total of 120 people need to be recruited from 1 medical centre."
Does the research project accept participants of legal adult age?
"As is outlined in the study's eligibility requirements, participants must be at least 18 years of age but no older than 55."
Are there any vacancies available for prospective participants in this experiment?
"Evidenced by clinicaltrials.gov, this medical trial is presently enrolling participants. It was introduced on April 6th 2021 and its content has been modified as recently as November 18th 2022."
What criteria must one meet to be eligible for enrollment in this clinical trial?
"This clinical trial is enrolling 120 individuals with obesity, aged between 18 and 55. Applicants must meet the following criteria: ages 18-45, right-handedness of at least +50 on the modified Edinburgh handedness scale, and BMI over 25.0."
What effects does the research team hope to observe from this trial?
"This clinical trial will evaluate the alteration of fat perception as measured by General Labeled Magnitude Scale, with assessments taking place at Baseline, 4 month, 8 month, and 16 months. Secondary objectives include monitoring changes in saturated fat intake via plasma cholesterol (measured at baseline and month 8) and triglycerides levels (also assessed at baseline and month 8). Additionally, 3-day food diaries processed through Nutrition Data System for Research should be utilised to track total solid fat intake over a period of 16 months from the start date."
What safety concerns should be taken into consideration when using RiduZone (90% OEA)?
"Our team at Power has assigned RiduZone (90% OEA) a safety rating of 3 due to the presence of prior clinical data verifying its efficacy and multiple studies validating it's secure usage."
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