Active not recruitingNAINTERVENTIONAL

Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient

This study aims to understand how a specific ingredient, called keratin hydrolysate, found in the Kera-Diet food supplement, might benefit our cells. We're asking young, healthy men to take this supplement. Afterwards, we'll collect their blood and look at how the blood, now containing special nutrients from the supplement, affects human cells grown in a lab. We want to compare these effects to blood from people who haven't taken the supplement. The main goal is to see if these nutrients can help cells stay healthy and work properly, even when they're under stress. This research helps us learn more about how diet might support cell health.

At a glance

Status

Active not recruiting

Phase

Sponsor

BCF Life Sciences

Enrolment target

Start

18 Nov 2024

Estimated completion

01 May 2025

Healthy

What is this study about?

You've probably heard that what you eat can affect your health. This study is exploring that idea by focusing on a specific ingredient called keratin hydrolysate, which is found in a food supplement called Kera-Diet. Hydrolysate simply means that the keratin has been broken down into smaller, easier-to-use parts.

The main aim of this research is to see if this keratin ingredient, after someone has eaten it, changes their blood in a way that could be good for human cells. To do this, we'll ask healthy volunteers to take the Kera-Diet supplement. We'll then collect a small amount of their blood. In a laboratory, we'll use this blood, which will now contain various nutrients from the supplement, to feed human cells grown in dishes. We'll compare how these cells behave to cells that are fed blood from people who haven't taken the supplement. We'll also look at cells that are put under a bit of 'stress' to see if the supplement's effects are particularly helpful then.

Ultimately, this study helps scientists understand if and how the nutrients from this supplement could support the normal functioning of our cells. It's about finding out more about how ingredients in food supplements might contribute to cell health, and these initial findings in the lab could pave the way for understanding potential benefits in the future.

Key takeaways

Tests how a specific nutrient, keratin hydrolysate, affects cells in a lab.
Aims to see if blood from young, healthy men who take a supplement can boost cell health.
Looks at how cells cope with stress when exposed to these special blood nutrients.
Participants must be healthy men aged 18-35 with specific health readings.
You'll take a supplement, have blood samples taken, and contribute to scientific understanding.

Who may be eligible?

This study is looking for healthy men between 18 and 35 years old. To join, your liver and kidney tests, as well as your blood counts and a marker of inflammation called CRP, need to be within healthy ranges. Your blood pressure also needs to be suitable for the study. You should weigh at least 60 kg and have a Body Mass Index (BMI) between 20 and 28. It's okay if you smoke occasionally, but no more than 5 cigarettes a day or a small amount of e-liquid. You also shouldn't do more than 5 hours of intense sports per week.

There are also some reasons why you wouldn't be able to join. For example, if you've had a vaccine in the last month, drink more alcohol than recommended, or are currently taking any medication, other supplements, or probiotics. If you have any known medical conditions, including common seasonal ones, or have allergies to keratin or certain amino acids, you won't be able to take part. This study also isn't suitable for those following vegetarian, vegan, or plant-based diets, or if your eating habits have changed recently. Finally, if a doctor involved in the study thinks your medical history isn't suitable, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man between 18 and 35 years old?
Do you have normal liver, kidney, and blood test results?
Do you weigh at least 60 kg with a BMI between 20 and 28?
Do you avoid smoking heavily or doing more than 5 hours of intense sports weekly?
Have you avoided any vaccinations in the last month?
Are you not currently taking any medications, other supplements, or probiotics?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to take the Kera-Diet supplement for a specific period. During this time, you would need to attend a few appointments for blood samples to be taken. These blood samples are important for us to see how your body has processed the supplement and what nutrients are then present in your blood. There will likely be an initial screening visit to check if you're suitable, followed by visits for taking the supplement and then blood collection. The full duration of your involvement, including all visits and follow-ups, would be explained in detail by the study team, but typically, this type of study involves a few weeks of participation.

Potential risks and benefits

The potential benefits of taking part in this study are mainly the contribution you would make to scientific research, helping us understand more about nutrition and cell health. You may also learn more about your own general health through the medical checks. As with any study, there are potential risks, primarily from blood draws, such as minor bruising or discomfort. There's also a small chance of an unexpected reaction to the supplement itself, though it's given to healthy individuals. You will be closely monitored by medical staff for your safety. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital, Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France

Common questions

What is keratin hydrolysate?

It's a broken-down version of keratin, a natural protein found in hair, skin, and nails. Breaking it down helps the body use it more easily.

Why is the study only looking at men?

Sometimes studies focus on one sex to keep the results clearer, as hormones and body differences can affect how ingredients work. This helps researchers understand the basic effects first.

What does 'stress conditions' for cells mean?

In a lab, 'stress' for cells can mean exposing them to things like mild inflammation or slightly tougher growing conditions. This helps researchers see if the supplement helps cells cope better.

Will I know if the supplement worked on my cells?

You won't get individual results about how your specific cells reacted. The study looks at the overall findings from all participants' blood samples.

Is the Kera-Diet supplement safe?

The supplement is being studied for its effects. The research team will provide full safety information and ensure all procedures are carried out responsibly. You will be monitored closely during the study.