Postprandial Amino Acid Response After Protein Consumption

NCT04935788 | Unknown

• 1 other identifier: NL78067.028.21
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• plasma AA

  postprandial plasma AA response

  5 hours

Secondary Outcomes (1)

• Insulin

  3 hours

Study Arms (4)

milk protein

EXPERIMENTAL

milk protein supplement

Dietary Supplement: milk protein

micellar casein

EXPERIMENTAL

casein supplement

Dietary Supplement: micellar casein

pea protein

EXPERIMENTAL

pea protein supplement

Dietary Supplement: pea protein

milk/pea protein

EXPERIMENTAL

a blend of milk and pea protein

Dietary Supplement: milk/pea protein blend

Interventions

milk protein DIETARY_SUPPLEMENT

milk protein supplement

milk protein

micellar casein DIETARY_SUPPLEMENT

micellar casein supplement

micellar casein

pea protein DIETARY_SUPPLEMENT

pea protein supplement

pea protein

milk/pea protein blend DIETARY_SUPPLEMENT

milk/pea protein supplement

milk/pea protein

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• NIZO Food Research: collaborator
• Ingredia S.A.: collaborator

Study Sites (1)

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Milk Proteins; Pea Proteins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Milk; Dairy Products; Food and Beverages; Plant Proteins, Dietary; Plant Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different conditions

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 23, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

NL (1)