Healthy
Conditions
Keywords
postprandial amino acids, appetite, beverages, healthy adults
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.
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.
Interventions
OTHERTest carbonated protein beverage
Participants will consume a carbonated test protein beverage
OTHERTest protein beverage
Participants will consume a beverage that contains a test protein.
OTHERControl protein beverage.
Participants will consume a beverage that contains a control protein.
OTHERControl non-carbonated beverage
Participants will consume a non-carbonated beverage that contains a test protein.
Sponsors
Shaklee Corporation
Biofortis Clinical Research, Inc.
Nlumn LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) above baseline for essential amino acids | Up to 2 hours post-beverage consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Individual and composite appetite visual analog scale (VAS) ratings | Up to 2 hours post-beverage consumption | Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling. |
Countries
United States
Contacts
STUDY_DIRECTORErin Barrett, PhD
Shaklee Coporation
PRINCIPAL_INVESTIGATORAditi Shah, MD
Biofortis Clinical Research, Inc.
Outcome results
None listed