BridgeMD
New treatment option for Bioavailability of Amino Acids
Official title Amino Acids in the Blood After Eating Yoghurt and Milk Proteins
ClinicalTrials.gov ID: NCT07243730
What this study is testing
- What it's testing
- Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 and ≤ 40 years at the time of (Informed Consent Form) ICF signature
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health.
You likely can't join if
- Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI)...
- Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute...
- Use of systemic medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production...
- Known Diabetes Mellitus Type I or Type II, insulin resistance, or metabolic syndrome.
- Any ongoing cancer and/or cancer treatment (except for non-melanoma skin cancer or carcinoma in situ).
- Known anaemia.
See the full eligibility criteria
- Age ≥ 18 and ≤ 40 years at the time of (Informed Consent Form) ICF signature
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed informed consent
- Willingness and ability to comply with the protocol
- Judged by the Investigator to be in good health.
- Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function in the opinion of the investigator, including but not limited to...
- Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney...
- Use of systemic medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism...
- Known Diabetes Mellitus Type I or Type II, insulin resistance, or metabolic syndrome.
- Any ongoing cancer and/or cancer treatment (except for non-melanoma skin cancer or carcinoma in situ).
- Known anaemia.
- A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening.
- Any known bleeding disorder.
- Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ ketogenic/ intermittent fasting/ high protein diet (\>1.6 g/kg body weight/day)) or a weight loss program.
- Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
- Known pregnancy and/or lactation.
- Current smoking / vaping / use of e-cigarette / or stopped smoking for \< 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/ e-cigarettes/ cigars/ pipes per week on average in the last month...
- Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women (on average during the last 6 months prior to screening).
- Drug or medicine abuse in the opinion of the investigator.
- Current eating disorders, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.
- Use of protein, amino acid, or creatine supplements within 4 weeks prior to screening.
- Known difficulties with placement of and/or blood drawings from a cannula.
- Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1.
- Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator.
- Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol requirements.
- Employees of Danone Global Research \& Innovation Center and of the investigational site and/or their family members or relatives.
The study team makes the final eligibility decision.
Where it's taking place
- Almere Stad, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almere Stad, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.