Proprietary Beverages for Appetite Hormone Response

Overseen By Biofortis Research Clinical Director

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Shaklee Corporation

Must not be taking: Dietary supplements

Disqualifiers: Weight loss, Eating disorder, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different proprietary beverages affect appetite hormones and feelings of hunger in generally healthy adults. Participants will try two study products, Study Product A and Study Product B, to observe how each influences appetite after meals. It suits individuals who regularly eat breakfast, have a BMI between 18.5 and 25, and are not on any weight loss plans. As an unphased trial, this study provides a unique opportunity to contribute to understanding how everyday beverages can impact appetite.

Will I have to stop taking my current medications?

The trial requires that any prescription medication use must be stable, meaning no change in dose or type, for at least 90 days before participating. If your medication use is stable, you may not need to stop taking it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining how Study Product A and Study Product B affect appetite hormones. However, clear information about their safety in humans remains limited. The trial is marked as "Not Applicable" for phase, indicating it may not be as advanced in testing as other treatments. This status suggests that detailed safety information may not yet be fully available.

Treatments in later stages typically undergo more extensive testing in humans, revealing any serious side effects. Without specific phase details or safety information, determining how well these products are tolerated is challenging.

Prospective participants should ask the researchers or healthcare providers for any available safety information. They can provide more details about what to expect when using these study products. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these proprietary beverages because they offer a novel approach to managing appetite by potentially influencing hormone responses. Traditional treatments for appetite control often rely on pharmaceuticals that can come with side effects or require long-term use. Unlike these standard treatments, these beverages might work naturally with the body's own hormonal signals, which could mean a more harmonious and potentially safer option for appetite management. By utilizing ingredients that are proprietary and possibly more aligned with the body's natural processes, these products aim to offer a fresh and innovative solution that could fill a gap in current appetite management strategies.

What evidence suggests that this trial's treatments could be effective for appetite hormone response?

This trial will compare the effects of Study Product A and Study Product B on appetite hormones. Research has shown that Study Product A has promising effects on hormones related to appetite. In an earlier study, participants maintained a 5% weight loss, linked to lower levels of leptin and insulin, hormones that help control hunger and energy use. Study Product B, another treatment option in this trial, showed similar results. Participants also maintained a 5% weight loss with reduced leptin and insulin levels. Both products appear to affect hormones that manage appetite, potentially aiding in weight management. ^{1 2 4 6 7}

Who Is on the Research Team?

Erin Barrett, PhD

Principal Investigator

Shaklee Corporation

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 20-50, with a BMI of 18.5-25 who regularly eat breakfast and have stable menstrual cycles or no hormonal contraceptive use. Participants must not be on weight loss plans, have recent substance abuse history, unstable medication use, certain medical conditions or surgeries that affect appetite, or financial ties to the study's company.

Inclusion Criteria

I am a woman with regular menstrual cycles or am post-menopausal.

Self-reported regular consumer of breakfast (≥5 days/week)

My BMI is between 18.5 and 25.

Exclusion Criteria

Recent history of alcohol or substance abuse within 12 months

I have lost or gained more than 4.5 kg in the last 3 months.

Currently following or planning to be on a weight loss regimen at any time prior to or during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume proprietary beverages and their post-meal appetite hormones and appetite ratings are assessed

4 weeks

Multiple visits for beverage consumption and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Study Product A
• Study Product B

Trial Overview The study tests two proprietary beverages: one with mixed macronutrients (Study Product A) and another with a single macronutrient (Study Product B). It measures how these drinks affect hunger hormones and self-reported appetite in healthy adults using questionnaires.

How Is the Trial Designed?

Group I: Study Product B followed by Study Product A Experimental Treatment 2 Interventions

Group II: Study Product A followed by Study Product B Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Shaklee Corporation

Lead Sponsor

Biofortis Clinical Research, Inc.

Industry Sponsor

Trials

12

Recruited

1,000+

Nlumn LLC

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9986487/

Levels of hormones regulating appetite and energy ... Results: Initial weight loss at T1 was maintained at T2 (−5.0%, p < 0.001), and accompanied by decreased leptin and insulin levels at T1 and T2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06966570

Acute Appetite Hormone Response of Proprietary Beverages The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, ...

3. nature.com nature.com/articles/s41366-025-01726-4

Fasting appetite-related gut hormone responses after ... Altered appetite-related gut hormone concentrations may reflect a physiological adaptation facilitating weight regain after weight loss.

4. sciencedirect.com sciencedirect.com/science/article/pii/S002231662208988X

Altered Appetite-Mediating Hormone Concentrations ... Women, relative to men, appeared to exhibit a greater decrement in glucose tolerance and experienced larger decreases in postprandial acyl ghrelin and fasting ...

5. joe.bioscientifica.com joe.bioscientifica.com/view/journals/joe/235/3/JOE-16-0570.xml

Appetite, food intake and gut hormone responses to intense ... The purpose of the study is to investigate the effect of acute bouts of high-intensity aerobic exercise of differing durations on subjective appetite, food ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796227/

Appetite Regulation: Hormones, Peptides, and ... This review examines energy homeostasis and food intake behaviors, specifically with regards to hormones, peptides, and neurotransmitters in the periphery and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02945475

Study Details | NCT02945475 | Neural Mechanisms for ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.