RiduZone for Weight Loss Maintenance

Overseen By Xu Davis, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Yale University

Must not be taking: Barbiturates, Benzodiazepines, others

Disqualifiers: Cancer, Alcoholism, Psychiatric illness, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called RiduZone helps maintain weight loss after the LEARN® weight loss program. The researchers aim to determine if dietary fat affects the effectiveness of RiduZone, which contains oleoylethanolamide (OEA), for weight maintenance. Participants will take either RiduZone or a placebo (a non-active pill) for 16 months. Suitable candidates for this trial have a BMI over 25, are comfortable with MRI scans, and enjoy milkshakes. As a Phase 4 trial, RiduZone has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking medications that affect alertness, such as barbiturates or benzodiazepines, to participate in this trial.

What is the safety track record for RiduZone?

Research shows that oleoylethanolamide (OEA), the main ingredient in RiduZone, may aid in weight management. Studies have examined its effects on appetite and fat breakdown. Importantly, OEA appears safe.

In one study, participants taking OEA supplements did not report major side effects. Another study found that OEA might also help with blood sugar levels and inflammation. These results suggest that OEA, and therefore RiduZone, is generally well-tolerated.

While detailed long-term safety data for RiduZone itself is lacking, its ongoing Phase 4 trial indicates that earlier studies have demonstrated its safety. Phase 4 trials typically confirm safety over a longer period, often after a treatment receives approval. This suggests that RiduZone is likely considered safe based on earlier research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard weight loss treatments that often focus on appetite suppression or calorie restriction, RiduZone is unique because it uses oleoylethanolamide (OEA), a naturally occurring compound in the body that regulates hunger and metabolism. Researchers are excited about RiduZone because OEA specifically targets fat metabolism, potentially offering a more natural and sustainable way to maintain weight loss. Additionally, RiduZone is administered in easy-to-take capsule form, making it a convenient option for long-term use compared to more invasive procedures or strict dietary plans.

What evidence suggests that RiduZone might be an effective treatment for weight loss maintenance?

Research has shown that oleoylethanolamide (OEA), the main ingredient in RiduZone, can help maintain weight loss. A review of several studies found that OEA supplements significantly reduced waist size in people with obesity. Another study found that taking 250 mg or more of OEA daily led to noticeable reductions in weight and Body Mass Index (BMI). OEA likely aids weight management by reducing appetite and increasing metabolism. In this trial, participants will receive either RiduZone, containing 90% OEA, or a placebo. These findings suggest that RiduZone could effectively help maintain weight loss. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English-speaking

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.

Exclusion Criteria

You have a serious mental health condition, such as an eating disorder, as defined in the DSM-IV.

You have had a pacemaker or neurostimulator implanted in the past.

You have a history of alcoholism or regular drug use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily supplementation with oleoylethanolamide (OEA) or placebo for weight loss maintenance

16 months

Monthly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RiduZone

Trial Overview

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.

How Is the Trial Designed?

Group I: RiduZone (90% Oleoylethanolamide (OEA)) Experimental Treatment 1 Intervention

Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA) daily for 16 months.

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 16-week study involving 140 overweight adults, the herbal extract LI85008F led to significant weight loss (5.36 kg) and reductions in BMI compared to a placebo group, indicating its efficacy for weight management.

Participants taking LI85008F also experienced improvements in their lipid profiles, with decreased LDL cholesterol and increased HDL cholesterol, and no major adverse events were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Dixit, K., Kamath, DV., Alluri, KV., et al.[2019]

In a review of 24 large randomized controlled trials on weight loss medications, total participant dropout rates were significantly influenced by the type of treatment, with placebo and certain medications showing higher attrition rates.

Implementing a pre-randomization lead-in period was associated with lower dropout rates (29.1% vs. 39.9%), and studies with a higher percentage of female participants also experienced greater attrition, indicating that study design and participant demographics are crucial for improving retention in obesity trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. Fabricatore, AN., Wadden, TA., Moore, RH., et al.[2022]

In a 6-month double-blind study involving 61 obese patients, sibutramine led to a significant weight loss of 7.3 kg (8% of initial weight) compared to only 2.6 kg (2.8%) in the placebo group, demonstrating its efficacy in managing obesity.

Sibutramine was well-tolerated, with side effects not leading to treatment discontinuation, although it did result in a slight increase in systolic blood pressure (5 mmHg).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. Halpern, A., Leite, CC., Herszkowicz, N., et al.[2019]

There are three main drugs approved for long-term obesity treatment: orlistat (5-8 kg weight loss but with gastrointestinal side effects), lorcaserin (4-7 kg weight loss with few side effects), and a combination of phentermine and topiramate (8-10 kg weight loss, but requires pregnancy verification).

For patients with chronic diseases like diabetes or depression, it's important to choose medications that not only treat the condition but also promote weight loss, as some drugs can cause weight gain or have a neutral effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. Bray, GA., Ryan, DH.[2014]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9369668/

Dietary adaptation for weight loss maintenance at Yale (DAWLY)

Here we investigate the impact of pre-intervention dietary fat intake on the efficacy of a dietary supplement to support weight loss maintenance.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12259213/

a systematic review and meta-analysis

[8] found that OEA supplementation (125 mg/day) in healthy obese individuals significantly reduced waist circumference, despite no changes in ...

3.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1553288/full

Oleoylethanolamide supplementation on cardiometabolic ...

The reduction in weight and BMI was significant at a dose ≥250 mg/day and in obese individuals. In addition, the BMI reduction was significant ...

4.

withpower.com

withpower.com/trial/phase-4-overweight-3-2021-30209

RiduZone for Weight Loss Maintenance · Info for Participants

In a 6-month double-blind study involving 61 obese patients, sibutramine led to a significant weight loss of 7.3 kg (8% of initial weight) compared to only 2.6 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0753332225003956

Anti-obesity effects of Oleoylethanolamide

This study investigated the effects of OEA administration on mice with diet-induced obesity, focusing on hepatic inflammation and mitochondrial function.

6.

scivisionpub.com

scivisionpub.com/pdfs/a-comprehensive-safety-profile-of-oleoylethanolamide-3241.pdf

A Comprehensive Safety Profile of Oleoylethanolamide

The anorexigenic and lipolytic effects of OEA make it a promising candidate for weight management. Despite structural similarities with the ...

7.

researchgate.net

researchgate.net/publication/381622132_A_Comprehensive_Safety_Profile_of_Oleoylethanolamide

A Comprehensive Safety Profile of Oleoylethanolamide

PDF | On Apr 30, 2024, Narendra S Deshmukh and others published A Comprehensive Safety Profile of Oleoylethanolamide | Find, read and cite ...