Primary: To compare postprandial plasma amino acid concentrations after ingestion of a fixed amount of protein from different dairy products in elderly subjectsSecondary: To determine effects of a fixed amount of protein from different dairy…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
voedingsfysiologie in gezonde personen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma amino acid concentrations before and at 13 timepoints (up till 5 hours)
after consumption of the dairy products
Secondary outcome
Plasma glucose and insulin concentrations at 9 out of the 14 time points.
Gastric emptying rate, based on 13CO2/12CO2 ratio in expired breath for up to 3
hours after meal consumption, and expressed as half-emptying time and lag
phase; and on postprandial acetaminophen concentrations in blood.
Subjective rating of appetite sensations (hunger, fullness, satiety, desire to
eat and prospective food consumption).
Background summary
Elderly need higher amino acid concentrations than younger people to achieve
similar muscle protein synthesis. A faster, higher postprandial peak of amino
acid concentrations and in particular leucine after consumption of different
types of proteins is associated with higher muscle protein synthesis. Many
studies have been performed with isolated proteins and very few with actual
consumer products.
Study objective
Primary: To compare postprandial plasma amino acid concentrations after
ingestion of a fixed amount of protein from different dairy products in elderly
subjects
Secondary: To determine effects of a fixed amount of protein from different
dairy products on:
• Postprandial plasma glucose and insulin concentrations
• Gastric emptying rate of the liquid and solid phase of products
• Feelings of satiation/satiety
Study design
Single-blinded within-subject design (cross-over) with 10 subjects receiving
each of 8 dairy products on separate test days, with one week washout period
between treatments.
Intervention
Single consumption of 8 different dairy products, on 8 separate test days, in a
portion size that contains 25g protein.
Study burden and risks
For this study healthy volunteers are selected. There is no direct benefit from
participation, although volunteers will be reimbursed for their time
investment. In total the subjects will visit the research lab 9 times (first
visit is screening visit). The study products consist of (mostly commercially
available) dairy products, and dairy proteins. There are restrictions with
respect to eating, drinking, and physical activity during the test days and on
the pre-test days. No restrictions or interventions apply on other days within
the study period. There are no risks associated with the consumption of the
test foods, nor with the use of the 13C tracer compounds or the breath
sampling. The amount of paracetamol given with the foods (1000 mg) is similar
to the recommended dosing for use as pain killer. Blood samples will be taken
14 times during each of these visits, during a 5 hour period. Blood will be
drawn via an infuse, which will be set by an experienced research nurse.
Exhaling breath into a sampling bag and completing the appetite scores are
simple noninvasive procedures.
Bronland 20
Wageningen 6708WH
NL
Bronland 20
Wageningen 6708WH
NL
Listed location countries
Age
Inclusion criteria
• Age over 60y
• BMI 21-30 kg/m2
• Non-smoking
• Healthy as assessed by the NIZO lifestyle and health questionnaire (*Verklaring leefgewoonten en gezondheid*).
• Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
• Veins suitable for cannulation (blood sampling)
• Voluntary participation
• Having given written informed consent
• Willing to comply with study procedures
• Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
• Accept disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
• Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
• Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
• Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric empyting (e.g. gastric acid inhibitors or laxatives)
• Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (>7 mmol/l in finger prick blood) as assessed during screening visit
• Use of protein supplements
• Mental status that is incompatible with the proper conduct of the study
• A self-reported reported food allergy or sensitivity to dairy ingredients
• A self-reported allergy or sensitivity to acetaminophen
• Alcohol consumption > 28 units/week and 4/day
• Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period
• Reported slimming or medically prescribed diet
• Recent blood donation (<1 month prior to Day 01 of the study)
• Not willing or afraid to give up blood donation during the study
• Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
• Not having a general practitioner
• Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results and eventual adverse events to and from his general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53912.081.15 |