Extended Release Protein Dosing

VitaKey Inc.

Status: Enrolling

Conditions: Nutrition

Treatments: Other: Extended release nutritional protein; Other: Control; Other: Negative Dose

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07313436

CLP0001

Details and patient eligibility

About

The overall goal of this study is to determine the minimum dose required to elicit measurable elevation of plasma essential amino acid levels 12 hours after consuming VitaKey's extended release protein technology. The results of this study will be used to set a dose for future protein clinical studies.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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21 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Other: Control

Low Dose Extended Release Protein

Experimental group

Treatment:

Other: Extended release nutritional protein

High Dose Extended Release Protein

Experimental group

Treatment:

Other: Extended release nutritional protein

Negative Dose Extended Release Protein

Experimental group

Treatment:

Other: Negative Dose