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

64 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug RiduZone for weight loss maintenance?

The meta-analysis of antiobesity compounds shows a strong correlation between early and longer-term weight loss, suggesting that early weight loss can predict longer-term success, which may apply to RiduZone as well. ^{1 2 3 4 5}

Is RiduZone safe for weight loss maintenance?

The research does not provide specific safety data for RiduZone, but it mentions that the long-term safety of weight loss drugs is a major concern, leading to the withdrawal of some medications. It's important to consult with a healthcare provider for personalized advice. ^{6 7 8 9 10}

How is RiduZone different from other weight loss drugs?

RiduZone is unique because it focuses on weight loss maintenance rather than just initial weight loss, which is a common focus of other treatments. It may involve a novel approach or formulation that helps maintain weight loss over time, unlike some treatments that primarily aim for short-term weight reduction. ^{3 4 11 12 13}

What is the purpose of this trial?

This trial tests if OEA, a natural body compound, can help people maintain weight loss by reducing cravings and helping them feel full. Oleoylethanolamide (OEA) has been shown to reduce appetite and body weight in obese people.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exploratory Literature Meta-Analysis to Characterize the Relationship Between Early and Longer Term Body Weight Loss for Antiobesity Compounds. [2018]

2. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Maximizing retention in long-term clinical trials of a weight loss agent: use of a dietitian support team. [2021]

4. England 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Commercial Programs' Online Weight-Loss Claims Compared to Results from Randomized Controlled Trials. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Adherence to weight loss medications; post-marketing study from HMO pharmacy data of one million individuals. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapies for obesity: past, current, and future therapies. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Tapencarium (RZL-012) for Flank Fat Reduction: A Proof-of-Concept Study. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Multi-factorial approach associated with a new 'on/off' Orlistat® use in a weight loss maintenance programme: 4 years follow-up. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Controlled-release diethylpropion hydrochloride used in a program for weight reduction. [2013]