Acute Appetite Hormone Response of Proprietary Beverages

NCT06966570 | Completed

• 1 other identifier: BIO-2503
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults.

Conditions

Healthy

Keywords

appetite, beverages, healthy adults

Outcome Measures

Primary Outcomes (1)

• Maximum concentration (Cmax) above baseline for appetite hormones

  Up to 2 hours post-beverage consumption

Secondary Outcomes (3)

• 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

• Individual and composite appetite visual analog scale (VAS) ratings

  Up to 2 hours post-beverage consumption

Study Arms (2)

Study Product A followed by Study Product B

OTHER

Other: Study Product A: Mixed-macronutrient beverage; Other: Study Product B: Single-macronutrient beverage

Study Product B followed by Study Product A

OTHER

Other: Study Product A: Mixed-macronutrient beverage; Other: Study Product B: Single-macronutrient beverage

Interventions

Study Product B: Single-macronutrient beverage OTHER

Participants will consume a beverage that contains a single macronutrient.

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

Study Product A: Mixed-macronutrient beverage OTHER

Participants will consume a beverage that contains mixed macronutrients.

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

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

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

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Study Officials

• Erin Barrett, PhD

  Shaklee Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 12, 2025
• Study Start: April 28, 2025
• Primary Completion: May 23, 2025
• Study Completion: June 11, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)