Slow-Release protein study aims to boost nutrients for half a day
NCT ID NCT07313436
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a new slow-release protein product to find the smallest amount that keeps essential amino acids in the blood for 12 hours. About 21 healthy adults aged 18-40 will take part. The results will help decide the right dose for future studies on nutrition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, 18 - 40 years of age, inclusive. 2. Body mass index (BMI) of 20 - 28 kg/m2, inclusive. 3. Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of Visit 1, with no plans to begin use during the study period. 4. Score of 7 to 10 on the Vein Access Scale at Visit 1. 5. No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history. 6. Willing to adhere to all study procedures, including lifestyle considerations (see section 6.3), 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: General health related criteria 1. Currently in a habitual exercise training program (≥ 3 d/wk of structured exercise) or plans to initiate an exercise training program during the study period. 2. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 d of visit 1). 3. History or presence of clinically important cardiac, renal, hepatic, endocrine, 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. 4. 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. 5. Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 d prior to testing. 6. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. 7. History of any major trauma or major surgical event within 2 months of visit 1. 8. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. Exclusionary products related criteria 9. Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits). 10. Recent use of anti-hyperglycemic (e.g., metformin, insulin, DPP 4 inhibitors, SGLT-2 inhibitors, GIP agonist, Pioglitazone, or Sulfonylureas) or GLP-1 analogue (e.g., Ozempic or Wegovy semaglutide, Mounjaro trizapatide) prescription medications within 6 mo of visit 1. 11. Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 d of visit 1. 12. Exposed to any non-registered drug product within 30 d of visit 1. 13. Antibiotic use within 30 d of visit 1 and throughout the study period. 14. Steroid use within 30 d of visit 1 and throughout the study period. 15. Current habitual user (≥ 3 days/week ≤ 30 d of visit 1) of anti-inflammatory medications (e.g., NSAIDs, acetaminophen, etc.). 16. Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products. Occasional use (e.g., couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 d washout prior to visit 1 and the participant must be willing to refrain from use during the study (sleep aids and topical lotions/creams are allowed). General safety related criteria 17. Known allergy or sensitivity to any ingredients or potential allergens contained in the study product or standard meals. 18. Self-report of blood donation totaling between 101-449 mL of blood within 30 d prior to visit 1 or a blood donation of ≥450 mL within 56 days prior to visit 1, or plasma donations within 48 h of visit 1. As well as any plans to donate blood or plasma during the study period. 19. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Biofortis
Addison, Illinois, 60101, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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