Extended Release Protein Dosing

NCT07313436 | Active Not Recruiting

• 1 other identifier: CLP0001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

• Plasma EAA positive incremental AUC5-12h (calculated as AUC0-12h - AUC0-5h) 5-12 h post-product consumption

  5-12 hours post consumption

Secondary Outcomes (22)

• Percent change in plasma leucine concentrations

  pre-product (t = 0) to 5 hours post consumption

• Positive incremental AUC0-12h 0-12 h post-product consumption and individual serum levels of Amylin.

  0-12 hours post consumption

• Maximum postprandial baseline-adjusted GI VAS scores over the 12 h in-clinic period (Overall abdominal symptoms, Abdominal bloating, Abdominal pain, Flatulence, Burping, Stomach rumbling, Nausea, Fatigue)

  0-12 hours post consumption

• Positive incremental AUC6-12h composite {[desire to eat + hunger + (100 - fullness) + prospective consumption]/4} appetite scores

  6-12 hours post consumption

• Positive incremental AUC6-12h food craving scores 6-12 h post-product: (Satisfaction, Thirst, Desire to snack, Food cravings, Sweet cravings, Salty cravings, Savory cravings, Fatty cravings)

  6 - 12 hours post consumption

Study Arms (4)

Control

PLACEBO COMPARATOR

Other: Control

Low Dose Extended Release Protein

EXPERIMENTAL

Other: Extended release nutritional protein

High Dose Extended Release Protein

EXPERIMENTAL

Other: Extended release nutritional protein

Negative Dose Extended Release Protein

EXPERIMENTAL

Other: Negative Dose

Interventions

Extended release nutritional protein OTHER

Participants will consume a beverage with extended release protein.

High Dose Extended Release Protein; Low Dose Extended Release Protein

Control OTHER

Participants will consume a beverage with standard nutritional protein.

Control

Negative Dose OTHER

Participants will consume a beverage with 15g less extended release protein than either the low dose cohort or the high dose cohort.

Negative Dose Extended Release Protein

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18 - 40 years of age, inclusive.
• Body mass index (BMI) of 20 - 28 kg/m2, inclusive.
• 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.
• Score of 7 to 10 on the Vein Access Scale at Visit 1.
• 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.
• 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.

You may not qualify if:

• General health related criteria
• 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.
• 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).
• 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.
• 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.
• 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.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• History of any major trauma or major surgical event within 2 months of visit 1.
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• 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).
• 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.
• 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.
• Exposed to any non-registered drug product within 30 d of visit 1.
• Antibiotic use within 30 d of visit 1 and throughout the study period.
• Steroid use within 30 d of visit 1 and throughout the study period.

Sponsors & Collaborators

• VitaKey Inc.: lead
• United States Department of Defense (DOD): collaborator

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 2, 2026
• Study Start: November 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)