The primary objective is to quantify the postprandial area under the curve (iAUC), the maximal level (Cmax) and the time profile (Tmax) of blood amino acids after ingestion of milk protein, micellar casein, pea protein, and a milk protein-pea…
ID
Source
Brief title
Condition
- Other condition
- Muscle disorders
Synonym
Health condition
sarcopenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial blood amino acid response, up to 5 hours after consumption of a
protein drink measured (incremental area under curve, Cmax and Tmax).
Secondary outcome
Postprandial insulin response
potential muscle effect as assessed by an vitro muscle assay
Background summary
Increasing muscle protein synthesis via protein-based nutrition, with or
without exercise, maintains a strong, healthy muscle mass, which in turn leads
to improved health, independence and functionality in older adults. There is
increased interest in plant-based proteins, but these have in general a lower
anabolic effect than animal proteins. Various strategies have been suggested to
augment the anabolic properties of plant proteins, including using plant-animal
protein blends. However, only little is known yet about the anabolic properties
of such an approach. As the peripheral metabolic availability of proteins is an
important aspect that has to be taken into account when screening the anabolic
properties of protein sources/blends, it is the aim of this study to
investigate the postprandial AA response of milk protein, micellar casein, pea
protein, and a milk protein-pea protein blend in healthy older adults.
Study objective
The primary objective is to quantify the postprandial area under the curve
(iAUC), the maximal level (Cmax) and the time profile (Tmax) of blood amino
acids after ingestion of milk protein, micellar casein, pea protein, and a milk
protein-pea protein blend in healthy older adults.
Secondary objectives are to quantify the postprandial insulin response, and to
quantify the potential muscular response, using an ex vivo muscle cell assay,
of postprandial blood derived from healthy older adults after ingestion of milk
protein, micellar casein, pea protein, and a milk protein-pea protein blend
Study design
The study is designed as a randomized, single-blinded within-subject
(cross-over) trial in which a group of 12 subjects receive 4 different protein
drinks.
Intervention
Four different protein drinks will be investigated: milk protein, micellar
casein, pea protein, and a milk protein/ pea protein blend. All drinks will
contain a 20 gram protein load. All protein supplements will be mixed with 250
mL water and contain some additional non-caloric flavorings
Study burden and risks
This study is related to older adults, as maintenance of muscle mass and
function * via protein based nutrition - is important in an ageing population.
Research participants will not directly benefit from their participation. The
risks associated with participation in this study are the development of
bruises due to cannulation and transiently decreased iron status due to
repeated blood sampling. The total amount of blood sampled during the 4 week
period is 480 ml (120 ml per week). Compared to the 500 ml which is collected
at a single occasion during blood donation, this amount is not expected to
result in side effects such as fatigue. The main burden of this study consists
of the time involved (4 days ~ 6 hours), and the blood collection.
Avenue F. Lobbedez CS 60646 51
Arras 62033 Cedex
FR
Avenue F. Lobbedez CS 60646 51
Arras 62033 Cedex
FR
Listed location countries
Age
Inclusion criteria
* Age *65 and *80
* BMI *20 and *32 kg/m2
* Non-smoking
* Healthy as assessed by a lifestyle and health questionnaire (*Verklaring
leefgewoonten en gezondheid*) and according to the judgment of the study
physician.
Exclusion criteria
* Having a history of medical or surgical events that may significantly affect
the study outcome
* Use of the following medication: glucose lowering drugs, insulin; medication
that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
* Diagnosed with diabetes, being treated for high blood glucose or increased
fasting blood glucose (> 6.7 mmol/l in finger prick blood) as assessed during
screening visit
* For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb
<7,5 mmol/l
* Use of protein supplements
Design
Recruitment
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 |
---|---|
ClinicalTrials.gov | NCT04935788 |
CCMO | NL78067.028.21 |