Acute Amino Acid Response of Proprietary Beverages

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

The primary objective of this study is to evaluate post-meal amino acid in response to a proprietary beverages in generally healthy adults.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Test protein beverage; Other: Control protein beverage.; Other: Test carbonated protein beverage; Other: Control non-carbonated beverage

Detailed Description

The primary objective of this study is to evaluate post-meal amino acid, appetite hormones, and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults compared to control. It is hypothesized that beverages will result in an increase in essential amnio acids, as well as appetite hormones and feelings of satiety, compared to control.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biofortis Clinical Research Clinical Director; Phone Number: 630-617-2000; Email: biofortisresearch@mxns.com

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Recruiting
      • Biofortis Clinical Research
      • Contact: Biofortis Clinical Research Director; Phone Number: 630.617.2000; Email: biofortisresearch@mxns.com
    • Addison, Illinois, United States, 60101
      • Not yet recruiting
      • Biofortis Clinical Research
      • Contact: Biofortis Research Clinical Director; Phone Number: 630-617-2000; Email: biofortisresearch@mxns.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test protein beverage followed by Control protein beverage	Other: Test protein beverage; Participants will consume a beverage that contains a test protein.; Other: Control protein beverage.; Participants will consume a beverage that contains a control protein.
Experimental: Control protein beverage followed by Test protein beverage	Other: Test protein beverage; Participants will consume a beverage that contains a test protein.; Other: Control protein beverage.; Participants will consume a beverage that contains a control protein.
Experimental: Test carbonated protein beverage followed by Control non-carbonated protein beverage	Other: Test carbonated protein beverage; Participants will consume a carbonated test protein beverage; Other: Control non-carbonated beverage; Participants will consume a non-carbonated beverage that contains a test protein.
Experimental: Control non-carbonated protein beverage followed by Test carbonated protein beverage	Other: Test carbonated protein beverage; Participants will consume a carbonated test protein beverage; Other: Control non-carbonated beverage; Participants will consume a non-carbonated beverage that contains a test protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) above baseline for essential amino acids	Up to 2 hours post-beverage consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax) above baseline for appetite hormones		Up to 2 hours post-beverage consumption
Positive area under the curve (AUC) for appetite hormones		Up to 2 hours post-beverage consumption
Time to Cmax (Tmax) for appetite hormones		Up to 2 hours post-beverage consumption
Positive area under the curve (AUC) for essential amino acids		Up to 2 hours post-beverage consumption
Time to Cmax (Tmax) for essential amino acids		Up to 2 hours post-beverage consumption
Individual and composite appetite visual analog scale (VAS) ratings	Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.	Up to 2 hours post-beverage consumption

Collaborators and Investigators

• Sponsor: Shaklee Corporation
• Collaborators: Biofortis Clinical Research, Inc.; Nlumn LLC
• Investigators: Study Director: Erin Barrett, PhD, Shaklee Coporation; Principal Investigator: Aditi Shah, MD, Biofortis Clinical Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: appetite; healthy adults; beverages; postprandial amino acids
• Other Study ID Numbers: BIO-2606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No