Evaluating appetite hormone responses to special beverages in healthy adults

A Randomized, Single-Blind, Crossover Pilot Trial to Assess the Effects of Proprietary Beverages on Acute Appetite Hormone Response in Healthy Adults

This study is testing how different types of drinks affect hunger hormones and feelings of fullness in healthy adults aged 20 to 50.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 20 Years to 50 Years
• Sex: All
• Sponsor: Shaklee Corporation (Industry-sponsored)
• Locations: 1 site (Addison, Illinois)
• Trial ID: NCT06966570 on ClinicalTrials.gov

What this trial studies

This study aims to assess how proprietary beverages affect post-meal appetite hormones and appetite ratings in generally healthy adults. Participants will consume either a mixed-macronutrient or a single-macronutrient beverage, and their responses will be measured using visual analog scale (VAS) questionnaires. The study hypothesizes that these beverages will enhance appetite hormones and feelings of satiety compared to baseline measurements. The research will involve regular consumers of breakfast aged 20 to 50 with a normal BMI.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 20 to 50 with a BMI between 18.5 and 25.0 who regularly consume breakfast.

Not a fit: Patients currently on a weight loss regimen or those with significant recent weight changes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how specific beverages can influence appetite regulation and satiety in healthy adults.

How similar studies have performed: While the specific approach of using proprietary beverages is novel, similar studies have explored appetite regulation and hormone responses with varying degrees of success.

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.

Where this trial is running

Addison, Illinois

• Biofortis Clinical Research — Addison, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Biofortis Research Clinical Director

Conditions Healthy; appetite, beverages, healthy adults