Amino Acids, Appetite, Gastrointestinal Tolerability
Conditions
Brief summary
The objective of this study is to compare the appearance of amino acids in circulation following consumption of two protein beverages in adults. Secondary objectives of this study are to assess changes in gastrointestinal tolerability, glycemia, markers of subjective and physiological appetite, and nausea.
Interventions
DIETARY_SUPPLEMENTProtein Powder
Contains 30 g of protein
DIETARY_SUPPLEMENTControl Protein Powder
Contains 30 g of protein
Sponsors
Midwest Center for Metabolic and Cardiovascular Research
The Hershey Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Male or female, between 25 and 54 years of age. * 2\. Individual has a body mass index (BMI) of 22.5 to 32.5 kg/m2. Only 5 participants will have a BMI of 30 to 32.5 kg/m2. * 3\. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements. * 4\. Individual is willing and able to undergo the scheduled study procedures. * 5\. Individual is willing to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit. * 6\. Individual is willing to abstain from alcohol consumption for at least 24 hours prior to each clinic visit. * 7\. Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion criteria
* 1\. Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee. * 2\. Individual has poor venous access and is not a good candidate for serial blood draws. * 3\. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 6 months of visit 1. * 4\. Individual has anemia (hemoglobin \<9 g/dL for females and \<11 g/dL for males). * 5\. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important gastrointestinal, cardiac, renal, hepatic, endocrine (e.g., type 1 or type 2 diabetes mellitus), pulmonary, 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. * 6\. Individual had a recent (within two weeks of screening) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea. * 7\. Individual has a history of frequent diarrhea or constipation that, in the opinion of the Investigator, could interfere with the interpretation of the study results. * 8\. Individual has a history of stomach or gastrointestinal surgery (e.g., gastric bypass, cholecystectomy) that in the opinion of the Investigator, could interfere with evaluation of the study outcomes. * 9\. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. * 10\. Individual uses medications (over-the counter or prescription) or dietary supplements known to influence gastrointestinal motility or digestion including laxatives, enemas, or suppositories; digestive enzyme supplements, proton pump inhibitors, H2 blockers, alpha-glucosidase inhibitors, antacids; prokinetic drugs; anti-diarrheal agents, anti-cholinergic drugs including anti-spasmodics; and fiber supplements. A 14-day washout phase prior to visit 2 (day 0) is allowed for participants taking any of these products. * 11\. Unstable use (initiation or change in dose) within 30 days of visit 1 of sex hormones. Multiphasic hormonal contraceptives in which the amount of sex hormone in the active pill varies by week (i.e., biphasic, triphasic, quadriphasic) are considered unstable doses of sex hormones and are exclusionary. * 12\. Use of any weight loss medication (including over-the-counter medications and/or supplements) within 30 days of visit 1. * 13\. Individual has used an alpha-blocker, beta-blocker, or high-dose diuretic within 30 days of visit 1. Unstable use (initiation or change in dose) within 30 days of visit 1 of other antihypertensive medications is also exclusionary. * 14\. Unstable use (initiation or change in dose) within 90 days of visit 1 of thyroid hormone replacement medications. * 15\. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg). * 16\. Individual has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix. * 17\. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit). * 18\. Individual regularly consumes (≥2 servings per week) protein supplements (including collagen) within 2 weeks of visit 2. * 19\. Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian). * 20\. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. * 21\. Individual has a known allergy or sensitivity to any ingredients in the study beverages or meals. * 22\. Individual has been exposed to any non-registered drug product within 30 days of the first screening visit. * 23\. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor). * 24\. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, 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 | Description |
|---|---|---|
| Total Amino Acid net incremental area under the curve (niAUC) | 5-12 hours post-beverage consumption | Difference between conditions in the niAUC for the total amino acid level in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amino Acids area under the curve (AUC) | 0-5 hours, 5-12 hours, 0-12 hours, and 8-12 hours | Differences between conditions in AUC for the total amino acid level in plasma |
| Total Amino Acids niAUC | 0-5 hours, 0-12 hours, and 8-12 hours | Difference between conditions in the niAUC for the total amino acid level in plasma |
| Maximum concentration for total amino acids | 0-12 hours | Difference between conditions in the maximum concentration for total amino acids in plasma |
| Baseline-adjusted maximum concentration for total amino acids | 0-12 hours | Difference between conditions in the baseline-adjusted maximum concentration for total amino acids in plasma |
| Time to maximum concentration for total amino acids | 0-12 hours | Differences between conditions in the time to maximum concentration for total amino acid levels in plasma |
| Glucagon-like peptide-1 AUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the AUC for glucagon-like peptide-1 |
| Glucagon-like peptide-1 niAUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the niAUC for glucagon-like peptide-1 |
| Peptide YY AUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the AUC for peptide YY |
| Peptide YY niAUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the niAUC for peptide YY |
| Ghrelin AUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the AUC for ghrelin |
| Ghrelin niAUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the niAUC for ghrelin |
| Glucose-dependent insulinotropic polypeptide AUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the AUC for glucose-dependent insulinotropic polypeptide |
| Glucose-dependent insulinotropic polypeptide niAUC | 0-5 hours, 5-12 hours, and 0-12 hours | Differences between conditions in the niAUC for glucose-dependent insulinotropic polypeptide |
| Markers of subjective appetite AUC | 0-5 hours, 5-12 hours, and 0-12 hours | Difference between conditions in the AUC for markers of subjective appetite (hunger, fullness, desire to eat, and prospective consumption) measured by the visual analog scale |
| Markers of subjective appetite niAUC | 0-5 hours, 5-12 hours, and 0-12 hours | Difference between conditions in the niAUC for markers of subjective appetite (hunger, fullness, desire to eat, and prospective consumption) measured by the visual analog scale |
| Essential Amino Acids AUC | 5-12 hours and 8-12 hours | Differences between conditions in AUC for the essential amino acid level in plasma |
| Essential Amino Acids niAUC | 5-12 hours and 8-12 hours | Difference between conditions in the niAUC for the essential amino acid level in plasma |
| Leucine AUC | 5-12 hours | Differences between conditions in AUC for the leucine level in plasma |
| Leucine niAUC | 5-12 hours | Difference between conditions in the niAUC for the leucine level in plasma |
| Maximum concentration for essential amino acids | 0-12 hours | Difference between conditions in the maximum concentration for essential amino acids in plasma |
| Maximum concentration for leucine | 0-12 hours | Difference between conditions in the maximum concentration for leucine in plasma |
| Total amino acids at t = 12 hours | t = 12 hours | Difference between conditions in the total amino acid level at t = 12 hours |
| Essential Amino Acids at t = 12 hours | t = 12 hours | Difference between conditions in the essential amino acid level at t = 12 hours |
| Baseline-adjusted maximum concentration for essential amino acids | 0-12 hours | Difference between conditions in the baseline-adjusted maximum concentration for essential amino acids in plasma |
| Baseline-adjusted maximum concentration for leucine | 0-12 hours | Difference between conditions in the baseline-adjusted maximum concentration for leucine in plasma |
| Time to maximum concentration for essential amino acids | 0-12 hours | Differences between conditions in the time to maximum concentration for essential amino acid levels in plasma |
| Time to maximum concentration for leucine | 0-12 hours | Differences between conditions in the time to maximum concentration for leucine levels in plasma |
Countries
United States
Outcome results
None listed