Real-time Amino Acid Profiling (RAP)

NIZO Food Research

Status: Completed

Conditions: Protein Digestion Kinetics

Treatments: Dietary Supplement: Dairy protein blend 1; Dietary Supplement: Dairy protein blend 4; Dietary Supplement: Dairy protein blend 2; Dietary Supplement: Whey protein; Dietary Supplement: Casein; Dietary Supplement: Dairy protein blend 3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03547362

NL65184.072.18

Details and patient eligibility

About

This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.

Enrollment: 12 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥65 and ≤80
• BMI ≥20 and ≤32 kg/m2
• Non-smoking
• Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.
• 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 1 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 emptying (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
• For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l.
• 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
• Alcohol consumption for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
• Reported unexpected 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 to give up blood donation during the study
• Personnel of NIZO food research and FrieslandCampina, 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 or her health, like laboratory results and eventual adverse events to and from his general practitioner

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 6 patient groups

Casein

Experimental group

Description:

Single oral administration

Treatment:

Dietary Supplement: Casein

Dairy protein blend 1

Experimental group

Description:

single oral administration

Treatment:

Dietary Supplement: Dairy protein blend 1

Whey protein

Experimental group

Description:

Single oral administration

Treatment:

Dietary Supplement: Whey protein

Dairy protein blend 2

Experimental group

Description:

Single oral administration

Treatment:

Dietary Supplement: Dairy protein blend 2

Dairy protein blend 3

Experimental group

Description:

Single oral administration

Treatment:

Dietary Supplement: Dairy protein blend 3

Dairy protein blend 4

Experimental group

Description:

Single oral administration

Treatment:

Dietary Supplement: Dairy protein blend 4