Acute Appetite Hormone Response of Proprietary Beverages

Launched by SHAKLEE CORPORATION · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how certain drinks affect appetite hormones and feelings of hunger after meals in healthy adults. The researchers want to see how these proprietary beverages influence appetite by measuring hormone levels and asking participants to rate their hunger using simple visual questionnaires. The trial is currently looking for participants between the ages of 20 and 50 who regularly eat breakfast and have a body mass index (BMI) within a healthy range.

To be eligible, participants need to be in good health without any recent significant weight changes or medical conditions that could affect their appetite. They should be willing to use a smartphone app to track their diet and follow specific study guidelines. Participants can expect to contribute to important research while helping to understand how different beverages impact hunger. If you’re interested and meet the criteria, this could be a great opportunity to participate in a meaningful study!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females, ≥20 to ≤50 years of age.
• • 2. BMI ≥18.5 and \<25.0 kg/m2.
• • 3. Self-reported regular consumer (≥5 days/week) of breakfast.
• • 4. Women who are either pre- or post-menopausal. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior.
• • 5. Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
• • 6. Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
• Exclusion Criteria:
• • 1. Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.
• • 2. Weight loss or gain \>4.5 kg within 90 days.
• • 3. History of gastrointestinal surgery for weight reducing purposes.
• • 4. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) or extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
• • 5. History of unconventional sleep patterns (e.g., night shift) or a diagnosed sleep disorder or chronic medical condition that may impact appetite (in the judgment of the Investigator).
• • 6. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months.
• • 7. Use of hemp/marijuana products within 60 days. Occasional use (e.g., once or twice a month) within 60 days is allowed.
• • 8. Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days.
• • 9. Unstable use (initiation or change in dose) within 30 days of hormonal contraceptives.
• • 10. Use of any dietary supplements, except for a conventional once daily multivitamin/mineral supplement.
• • 11. Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
• • 12. Exposed to any non-registered drug product within 30 days prior.
• • 13. A score of \<7 on the Vein Access Scale Assessment.
• • 14. History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
• • 15. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
• • 16. Known allergy to any ingredients contained in the study product or study foods.
• • 17. Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days.
• • 18. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• • 19. History of any major trauma or major surgical event within 2 months.
• • 20. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose within 30 days) of sex hormones for contraception.
• • 21. An employee or representative who has a financial interest in Shaklee Corporation.
• • 22. Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.