RECRUITING

Acute Appetite Hormone Response of Proprietary Beverages

Conditions

Healthy appetite, beverages, healthy adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01

Study Completion:2025-05-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06966570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Biofortis Research Clinical Director

CONTACT

(630) 617-2000

biofortisresearch@mxns.com

Principal Investigator

Erin Barrett, PhD

STUDY_DIRECTOR

Shaklee Corporation

Study Locations (Sites)

Biofortis Clinical Research

Addison, Illinois, 60101

United States

Collaborators and Investigators

Sponsor: Shaklee Corporation

Erin Barrett, PhD, STUDY_DIRECTOR, Shaklee Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2025-05-23

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2025-05-23

Terms related to this study

Keywords Provided by Researchers

appetite, beverages, healthy adults

Additional Relevant MeSH Terms

Healthy