Extended Release Protein for Nutrition
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new extended-release protein technology to assess its impact on essential amino acid levels in the body. Researchers aim to determine the smallest effective dose that elevates amino acid levels 12 hours after consumption. Participants will receive either a high, low, or negative dose of the extended-release nutritional protein, or a placebo for comparison. Non-smokers with a BMI between 20 and 28 may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in nutritional science.
Will I have to stop taking my current medications?
The trial requires that you have stable use of any prescription medication, meaning no changes in dose or type within 90 days before the study starts. Some medications, like antibiotics and steroids, must not be used within 30 days before the study and during the study period. If you use anti-inflammatory medications regularly, you may need to stop before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that extended-release nutritional protein is usually safe for people. Although specific data on this exact type is lacking, similar proteins have been studied before. These studies suggest that such proteins don't cause major side effects when consumed. However, minor issues like skin redness, eye irritation, or stomach discomfort might occur with direct contact or large amounts.
This type of protein is used in many products and is considered safe to consume. The trial is testing different doses, so researchers will closely monitor any new side effects. Overall, existing research supports the safety of nutritional proteins like this one, making them a good choice for further study.12345Why are researchers excited about this trial?
Researchers are excited about the Extended Release Nutritional Protein because it offers a new way to deliver essential nutrients over a prolonged period. Unlike current nutritional supplements, which require frequent dosing, this extended-release formula could simplify nutrition management by providing a steady supply of protein with fewer doses. This could be particularly beneficial for individuals who need consistent nutrient intake but struggle with regular supplementation. The trial is testing various doses to determine the most effective and convenient option, potentially transforming how we approach nutritional support.
What evidence suggests that this trial's treatments could be effective?
Studies have shown that extended-release protein effectively increases important amino acids in the blood. This protein releases nutrients slowly, providing a steady supply to the body. Research indicates that protein supplements can improve muscle mass and strength, especially with regular use. Additionally, protein supplements help control appetite and improve overall nutrition. This trial will evaluate different dosages of extended-release protein—high dose, low dose, and negative dose—to determine their effects on maintaining energy levels and supporting muscle health over a longer period.678910
Are You a Good Fit for This Trial?
This trial is for healthy men and women aged 18-40 with a BMI of 20-28. Participants must not use tobacco or nicotine, agree to follow study rules, sign consent forms, and have good vein access for blood draws. They can't have health issues that would interfere with the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive different doses of VitaKey's extended release protein technology to determine the minimum dose required for measurable elevation of plasma essential amino acid levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Extended Release Nutritional Protein
Trial Overview
The study tests VitaKey's extended release protein to find the smallest dose that raises essential amino acid levels in the blood after 12 hours. It compares this new protein form against a control group and different dosages.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
VitaKey Inc.
Lead Sponsor
United States Department of Defense (DOD)
Collaborator
Citations
Effectiveness of Protein-enriched oral nutritional ...
This study evaluated the effects of protein-enriched oral nutritional supplementation (ONS) consumption for 12 weeks on muscle mass, muscular strength, and ...
The Impact of Protein Supplementation on Appetite and ...
The bar suppressed appetite ratings compared with control and gel. However, when total EI was examined, there was a significant increase in total EI with both ...
The effectiveness of protein supplements on athletic ...
The outcomes included time to exhaustion, lower body strength, upper body strength, one-repetition maximum (1 RM), cycling time trials, maximum ...
Extended Release Protein for Nutrition
The study tests VitaKey's extended release protein to find the smallest dose that raises essential amino acid levels in the blood after 12 hours ...
High-protein oral nutritional supplement use in patients ...
Introduction: Oral nutritional supplements (ONS) have been reported to improve nutritional status, quality of life and clinical outcomes in many patient groups.
Safety Data Sheet Whey Protein
Fire/decomposition may produce irritating and/or toxic gases, including oxides of Carbon. Release of Invisible Flammable. Vapours and Gases.
SAFETY DATA SHEET
Exposure Limits: This material is a particulate matter and adequate inhalation/respiratory protection should be used to minimize exposure. No ...
Safety Data Sheet Trade Name: BPI Protein
Potential Health Effects: Inhalation: No data available. Eyes: No data available. Eye exposure may cause irritation, redness and watering. Skin: ...
SAFETY DATA SHEET RECOMBINANT PROTEIN
Ingestion. May cause discomfort if swallowed. Skin contact. Prolonged skin contact may cause redness and irritation. Eye contact. May cause temporary eye ...
Safety Data Sheet for Protein A (S1425) EUE
Use personal protection equipment. SECTION 6: Accidental release measures. 6.1. Personal precautions, protective equipment and emergency ...
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