Effects of different protein beverages on post-meal amino acids and appetite

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

We will test whether different proprietary protein beverages change post-meal amino acid levels, appetite hormones, and feelings of fullness in generally healthy adults aged 20 to 50.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 20 Years to 50 Years
• Sex: All
• Sponsor: Shaklee Corporation (Industry-sponsored)
• Locations: 2 sites (Addison, Illinois and 1 other locations)
• Trial ID: NCT07534020 on ClinicalTrials.gov

What this trial studies

This study compares four beverage formulations — a carbonated protein beverage, a non-carbonated protein beverage, a control protein beverage, and a non-protein control beverage — in generally healthy adults. Participants consume each beverage and provide blood samples over the post-meal period to measure amino acids and appetite-related hormones, and they complete visual analog scale questionnaires to rate hunger and fullness. The primary outcomes are changes in essential amino acids, appetite hormone levels, and self-reported satiety after the beverages compared to control. The within-subject design captures postprandial responses over time to determine formulation-specific effects.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men and women aged 20–50 with a BMI of 18.5–25 who regularly eat breakfast, can attend visits in Addison, Illinois, and are willing to use a smartphone app for diet records.

Not a fit: People actively trying to lose weight, those with recent large weight changes, a history of certain gastrointestinal surgery, or chronic conditions or medications that affect appetite may not receive benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could identify beverage formulations that boost essential amino acids and increase short-term feelings of fullness, which might help with appetite control and nutrition planning.

How similar studies have performed: Previous research has shown that protein-containing beverages raise postprandial amino acid levels and can increase short-term satiety, but this trial tests specific proprietary formulations and the effect of carbonation.

Eligibility criteria

Inclusion Criteria:

1. Males and females, ≥20 to ≤50 years of age.
2. Body mass index (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 nonmelanoma 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 and 1 other locations

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

Study contacts

• Principal investigator: Aditi Shah, MD — Biofortis Clinical Research, Inc.
• Study coordinator: Biofortis Clinical Research Clinical Director

Conditions Healthy; postprandial amino acids; appetite; beverages; healthy adults