Real-time Amino Acid Profiling

NCT03547362 | Completed

• 1 other identifier: NL65184.072.18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Protein Digestion Kinetics

Keywords

Amino acids; Dairy proteins; Postprandial; Older adults

Outcome Measures

Primary Outcomes (1)

• Postprandial serum amino acid concentration

  Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.

  0-300 min after consumption

Study Arms (6)

Casein

EXPERIMENTAL

Single oral administration

Dietary Supplement: Casein

Dairy protein blend 1

EXPERIMENTAL

single oral administration

Dietary Supplement: Dairy protein blend 1

Whey protein

EXPERIMENTAL

Single oral administration

Dietary Supplement: Whey protein

Dairy protein blend 2

EXPERIMENTAL

Single oral administration

Dietary Supplement: Dairy protein blend 2

Dairy protein blend 3

EXPERIMENTAL

Single oral administration

Dietary Supplement: Dairy protein blend 3

Dairy protein blend 4

EXPERIMENTAL

Single oral administration

Dietary Supplement: Dairy protein blend 4

Interventions

Casein DIETARY_SUPPLEMENT

See arm description

Casein

Dairy protein blend 1 DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 1

Whey protein DIETARY_SUPPLEMENT

See arm description

Whey protein

Dairy protein blend 2 DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 2

Dairy protein blend 3 DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 3

Dairy protein blend 4 DIETARY_SUPPLEMENT

See arm description

Dairy protein blend 4

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• NIZO Food Research: lead
• FrieslandCampina: collaborator

Study Sites (1)

NIZO Food Research

Ede, Gelderland, 6718ZB, Netherlands

Location

MeSH Terms

Interventions

Caseins; Whey Proteins

Intervention Hierarchy (Ancestors)

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

Study Officials

• Melle van Schaik

  NIZO Food Research

  STUDY DIRECTOR

Study Design

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

Model Details: The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: June 6, 2018
• Study Start: May 30, 2018
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)