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RiduZone for Weight Loss Maintenance

Phase 4
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-45
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 month, 8 month, 16 month
Awards & highlights

Study Summary

This trial will test if a fat- intake can help improve weight-loss maintenance after a weight-loss program.

Who is the study for?
This trial is for adults aged 18-45 with a BMI over 25 who are comfortable with fMRI procedures and enjoy milkshakes. Participants must be right-handed, English-speaking, and without serious medical conditions, drug abuse history, major psychiatric disorders, or medications affecting alertness.Check my eligibility
What is being tested?
The study aims to see if RiduZone (containing OEA) helps maintain weight loss after the LEARN program compared to a placebo. It focuses on individuals who consume high-fat diets and examines how fat intake influences the effects of OEA.See study design
What are the potential side effects?
Potential side effects of RiduZone (OEA) are not detailed in this summary but could include digestive discomfort or changes in appetite. Placebos typically have no active ingredients but can cause perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 month, 8 month, 16 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 month, 8 month, 16 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in absolute body weight
Change in body fat percent
Change in brain response to milkshake
+38 more
Secondary outcome measures
Change in 3-day food diary total solid fat intake
Change in Healthy Eating Index (HEI)
Change in saturated fat intake measured by plasma cholesterol
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RiduZone (90% Oleoylethanolamide (OEA))Experimental Treatment1 Intervention
Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA) daily for 16 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,548 Total Patients Enrolled
60 Trials studying Obesity
248,148 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,066 Total Patients Enrolled
447 Trials studying Obesity
588,938 Patients Enrolled for Obesity

Media Library

RiduZone (90% OEA) Clinical Trial Eligibility Overview. Trial Name: NCT04614233 — Phase 4
Obesity Research Study Groups: RiduZone (90% Oleoylethanolamide (OEA)), Placebo
Obesity Clinical Trial 2023: RiduZone (90% OEA) Highlights & Side Effects. Trial Name: NCT04614233 — Phase 4
RiduZone (90% OEA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614233 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Modern Diet and Physiology Research Lab
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~66 spots leftby Dec 2027