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Official title Acute Amino Acid Response of Proprietary Beverages
ClinicalTrials.gov ID: NCT07534020
What this study is testing
- What it's testing
- The primary objective of this study is to evaluate post-meal amino acid in response to a proprietary beverages in generally healthy adults.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Males and females, ≥20 to ≤50 years of age.
- Body mass index (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...
- Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
You likely can't join 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...
- History of unconventional sleep patterns (e.g., night shift) or a diagnosed sleep disorder or chronic medical condition that may impact appetite (in...
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months.
See the full eligibility criteria
- Males and females, ≥20 to ≤50 years of age.
- Body mass index (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...
- 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...
- 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...
- 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...
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
- Known allergy to any ingredients contained in the study product or study foods.
- Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days.
- History or presence of cancer in the prior 2 years, except for nonmelanoma skin cancer.
- History of any major trauma or major surgical event within 2 months.
- 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.
- An employee or representative who has a financial interest in Shaklee Corporation.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Addison, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addison, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.