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Postprandial Amino Acid Response After Protein Consumption (PAR)

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
milk protein
micellar casein
pea protein
milk/pea protein blend
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥60 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.
  • Regular and normal Dutch eating habits as assessed by a 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 or plant 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
  • 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

Sites / Locations

  • Division of Human Nutrition, Wageningen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

milk protein

micellar casein

pea protein

milk/pea protein

Arm Description

milk protein supplement

casein supplement

pea protein supplement

a blend of milk and pea protein

Outcomes

Primary Outcome Measures

plasma AA
postprandial plasma AA response

Secondary Outcome Measures

Insulin
postprandial insulin response

Full Information

First Posted
June 11, 2021
Last Updated
June 23, 2021
Sponsor
Wageningen University
Collaborators
NIZO Food Research, Ingredia S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04935788
Brief Title
Postprandial Amino Acid Response After Protein Consumption
Acronym
PAR
Official Title
The Acute Postprandial Response of Blood Amino Acids in Older Adults After Consumption of Dairy Protein, Plant Protein and Their Blend
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
NIZO Food Research, Ingredia S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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 in vitro 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. Study population: Healthy older adults (60-80 years) Intervention (if applicable): 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. Main study parameters/endpoints: Postprandial blood amino acid response, up to 5 hours after consumption of a protein drink measured (incremental area under curve, Cmax and Tmax).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different conditions
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
milk protein
Arm Type
Experimental
Arm Description
milk protein supplement
Arm Title
micellar casein
Arm Type
Experimental
Arm Description
casein supplement
Arm Title
pea protein
Arm Type
Experimental
Arm Description
pea protein supplement
Arm Title
milk/pea protein
Arm Type
Experimental
Arm Description
a blend of milk and pea protein
Intervention Type
Dietary Supplement
Intervention Name(s)
milk protein
Intervention Description
milk protein supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
micellar casein
Intervention Description
micellar casein supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
pea protein
Intervention Description
pea protein supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
milk/pea protein blend
Intervention Description
milk/pea protein supplement
Primary Outcome Measure Information:
Title
plasma AA
Description
postprandial plasma AA response
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Insulin
Description
postprandial insulin response
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥60 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. Regular and normal Dutch eating habits as assessed by a 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 or plant 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 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
Facility Information:
Facility Name
Division of Human Nutrition, Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703 HA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Postprandial Amino Acid Response After Protein Consumption

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