The present study compares the postprandial amino acid uptake kinetics between a commercially available (fermented) yoghurt vs a commercially available (pasteurized) milk matched for protein, and small differences on fat, calories, and volume.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gezonde deelnemers, dus geen aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare product A vs product B by means of total postprandial blood amino
acid concentrations expressed as incremental Area Under the Curve iAUC.
Secondary outcome
o compare product A vs product B by means of essential postprandial blood amino
acid (EAA) concentrations expressed as incremental Area Under the Curve iAUC.
To compare product A vs product B by means of maximum incremental concentration
(iCmax) of total postprandial blood amino acids (TAA) and as time until maximum
concentration (Tmax).
To compare product A vs product B by means of maximum incremental concentration
(iCmax) of essental postprandial blood amino acids (EAA) and as time until
maximum concentration (Tmax).
Background summary
Milk is the first source of protein consumed by humans as neonates, and later
in life milk is still an important source of protein in the human diet past
infancy. Dairy proteins can be either consumed as the milk product itself but
may also be consumed as yoghurt, cheese, or in further processed food products
containing milk proteins as an ingredient. Yoghurt is a fermented milk and
fermented foods in general gained interest in the past decade related to
potential benefits. Fermented dairy products in particular have received
attention for their potential to impact human health.
Protein uptake kinetics is not only dependent on pH but is also influenced by a
number of other factors. Horstman & Huppertz described that Amino Acid
availability is affected by gastric emptying which in turn can be altered by
heat treatment, fat content, calorie density, casein content, and
homogenization of milk among others. Based on these factors it could be
hypothesized that yoghurt would result in faster gastric emptying and thus in
improved amino acid uptake kinetics as compared to milk.
Study objective
The present study compares the postprandial amino acid uptake kinetics between
a commercially available (fermented) yoghurt vs a commercially available
(pasteurized) milk matched for protein, and small differences on fat, calories,
and volume.
Study design
This study adopts a randomised controlled, open-label, crossover, single-centre
proof of concept design.
Intervention
Two study products will be investigated, both commercially available dairy
products being a fermented milk product and a non-fermented milk product:
Product A: Yoghurt
Product B: Full fat pasteurized Milk
Study burden and risks
Both 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 both widely commercially
available in supermarkets as both *over-the-counter* products. There are no
known undesirable effects after intake of the study product (both test and
control product). The amount of protein consumed per study visit (20 grams) is
approximately one third to one fourth of the daily recommended dose for an
average adult. Therefore, there are no serious tolerance issues or other safety
issues to be expected with the amounts used in this clinical study. There might
be some GI related discomfort after consuming a bolus of study product, such as
belching, feeling of fullness, or possibly nausea since the volume of both
study products to be taken within the 10 minutes (+/-5 min) may be not common
use for the study participants.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
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 <= 27.0 kg/m2
3. Written 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 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).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL87793.056.24 |