The objective of this study is to determine the EAA bioavailability in the blood circulation after ingestion of three high-protein dairy products, that differ in their AA composition
ID
Source
Brief title
Condition
- Other condition
Synonym
Research involving
Sponsors and support
Intervention
- Food (substances)
N.a.
Outcome measures
Primary outcome
<p>To determine during the 5-hour postprandial period following ingestion of three high-protein, yogurt-cultured, dairy products the maximum concentration (Cmax) of essential amino acids in the blood circulation. </p>
Secondary outcome
<p>To determine during the 5-hour postprandial period following ingestion of three high-protein, yogurt-cultured, dairy products: </p><ul><li>The Cmax of serum or plasma total amino acids (TAAs), non-essential amino acids (NEAAs), and branch-chain amino acids (BCAAs) . </li><li>The amount of leucine, EAA, TAA, NEAA, and BCAA concentrations appearing in the serum/plasma (iAUC) during the full postprandial period (iAUC0-300), early phase postprandial period (iAUC0-120), and late phase postprandial period (iAUC120-300). </li><li>The time at which maximum serum/plasma leucine, EAAs, TAAs, NEAAs, and BCAAs concentrations occur (Tmax). </li><li>Correlation coefficients between postprandial Cmax and iAUC of serum/ plasma leucine concentrations and amount of whey ingested (absolute amount [g] and amount corrected for body weight [g/kg]). </li><li>Appetite-related measurements (satiety, fullness, hunger, and prospective food consumption), and their Composite Satiety Score (CSS). </li></ul>
Background summary
The ingestion of dietary protein increases muscle protein synthesis rates. The anabolic properties of a dietary protein source are determined in large part by its amino acid (AA) composition and digestion and AA absorption characteristics. Plasma essential AA (EAA), availability has been well established as a key modulatory factor for stimulating muscle protein synthesis rates.
High-protein dairy products are increasingly available on the market. These high-protein dairy products can contain up to 70% of its energy content as protein, and vary in the amount of EAAs they contain.
Study objective
The objective of this study is to determine the EAA bioavailability in the blood circulation after ingestion of three high-protein dairy products, that differ in their AA composition
Study design
This study applies a randomized, open-label, crossover, single-center, exploratory design.
Intervention
3 high-protein, yoghurt-cultured dairy products that vary in the amount of EAAs they contain.
Study burden and risks
All study products are intended to be consumed by general population, therefore there is no safety concern with the use of the study products in healthy volunteers in this study. The protein products that will be tested in this study are safe for human consumption and are commercially available in supermarkets as ‘over the counter’ products. There are no known undesirable effects after intake of the study products. The amount of protein consumed per study visit (20 grams) is approximately one third to one fourth of the daily recommended intake of protein for an average adult. Therefore, there are no serious tolerance issues or other safety issues to be expected with the amounts used in this study.
E. Gerrits
Uppsalalaan 12
Utrecht 3584CT
Netherlands
+31642992789
eva.gerrits@danone.com
E. Gerrits
Uppsalalaan 12
Utrecht 3584CT
Netherlands
+31642992789
eva.gerrits@danone.com
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
1. Age ≥ 18 and ≤ 40 years at the time of ICF signature
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Signed informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health
Exclusion criteria
1. Any known surgery or ongoing medical condition that interferes significantly with protein
absorption and digestion, and/or gastrointestinal (GI) function (e.g. phenylketonuria,
pancreatitis, short bowel syndrome, inflammatory bowel disease, gastroesophageal reflux
disease, celiac disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, oesophageal
and/or gastric surgery), in the opinion of the investigator.
2. Known renal or hepatic diseases that may interfere with protein metabolism, including
but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic
kidney disease, in the opinion of the investigator.
3. 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 (for example: antibiotics, anticonvulsants,
prokinetics, antacids or gastric acid inhibitors, opioid analgesics, anticoagulants,
corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or
insulin).
4. Known Diabetes Mellitus type I or type II, insulin resistance, or metabolic syndrome.
5. Any ongoing cancer and/or cancer treatment (except for non-melanoma skin cancer or
carcinoma in situ).
6. Known anaemia.
7. A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women;
prior to the screening.
8. Any known bleeding disorder.
9. 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.
10. Any known allergies or intolerances to ingredients of the study product, i.e. cow’s milk
allergies, lactose intolerance.
11. Known pregnancy and/or lactation.
12. 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 prior to screening).
13. 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).
14. Drug or medicine abuse in opinion of the investigator.
15. Current eating disorder, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.
16. Use of protein, amino acid, or creatine supplements within 4 weeks prior to screening.
17. Known difficulties with placement of and/or blood drawings from a cannula.
18. Participation in any other clinical study with investigational or marketed products
concomitantly or within four weeks before study visit 1.
19. 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.
20. Investigator’s uncertainty about the willingness or ability of the participant to comply
with the protocol requirements.
21. Employees of Danone Research and of the investigational site and/or their family
members or relatives.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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Research portal | NL-009439 |