Acute Amino Acid Response of Proprietary Beverages

NCT07534020 | Recruiting

• 1 other identifier: BIO-2606
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

postprandial amino acids; appetite; beverages; healthy adults

Outcome Measures

Primary Outcomes (1)

• Maximum concentration (Cmax) above baseline for essential amino acids

  Up to 2 hours post-beverage consumption

Secondary Outcomes (6)

• 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

• 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

Study Arms (4)

Study Product A followed by Study Product B

EXPERIMENTAL

Other: Study Product A: protein beverage; Other: Study Product B: control protein beverage.

Study Product B followed by Study Product A

EXPERIMENTAL

Other: Study Product A: protein beverage; Other: Study Product B: control protein beverage.

Study Product C followed by Study Product D

EXPERIMENTAL

Other: Study Product C: carbonated test protein beverage.; Other: Study Product D

Study Product D followed by Study Product C

EXPERIMENTAL

Other: Study Product C: carbonated test protein beverage.; Other: Study Product D

Interventions

Study Product C: carbonated test protein beverage. OTHER

Participants will consume a non-carbonated test protein beverage.

Study Product C followed by Study Product D; Study Product D followed by Study Product C

Study Product A: protein beverage OTHER

Participants will consume a beverage that contains a test protein.

Study Product A followed by Study Product B; Study Product B followed by Study Product A

Study Product B: control protein beverage. OTHER

Participants will consume a beverage that contains a control protein.

Study Product A followed by Study Product B; Study Product B followed by Study Product A

Study Product D OTHER

Participants will consume a non-carbonated beverage that contains a test protein.

Study Product C followed by Study Product D; Study Product D followed by Study Product C

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, ≥20 to ≤50 years of age.
• BMI ≥18.5 and \<25.0 kg/m2.
• Self-reported regular consumer (≥5 days/week) of breakfast.
• 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.
• Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
• 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.

You may not qualify if:

• Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.
• Weight loss or gain \>4.5 kg within 90 days.
• History of gastrointestinal surgery for weight reducing purposes.
• 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.
• 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).
• Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months.
• Use of hemp/marijuana products within 60 days. Occasional use (e.g., once or twice a month) within 60 days is allowed.
• Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days.
• Unstable use (initiation or change in dose) within 30 days of hormonal contraceptives.
• Use of any dietary supplements, except for a conventional once daily multivitamin/mineral supplement.
• Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
• Exposed to any non-registered drug product within 30 days prior.
• A score of \<7 on the Vein Access Scale Assessment.
• 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.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).

Sponsors & Collaborators

• Shaklee Corporation: lead
• Biofortis Clinical Research, Inc.: collaborator
• Nlumn LLC: collaborator

Study Sites (2)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

NOT YET RECRUITING

Biofortis Clinical Research

Addison, Illinois, 60101, United States

RECRUITING

Study Officials

• Erin Barrett, PhD

  Shaklee Coporation

  STUDY DIRECTOR

• Aditi Shah, MD

  Biofortis Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biofortis Clinical Research Clinical Director

CONTACT

630-617-2000; biofortisresearch@mxns.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)