Protein Digestibility in Older and Younger Adults

NCT05534464 | Completed

• 1 other identifier: NL80529.091.22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to determine the difference in amino acid digestibility of milk, sorghum and black beans between older (65-80 years) and younger (20-35 years) adults using the dual tracer method.

Conditions

Ageing

Outcome Measures

Primary Outcomes (1)

• Amino acid digestibility of three different protein sources

  Ratio between meal and plasma isotope enrichment in amino acids

  1 measurement repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out

Secondary Outcomes (4)

• Linear increase in plasma amino acids of three different protein sources

  11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out

• Area under the curve for plasma amino acid concentration of three different protein sources

  11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out

• Steady state plasma amino acid concentration of three different protein sources

  11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out

• Plasma gut health markers of the participants in relation to age and amino acid digestibility

  1 blood sample before consumption of the protein source, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out

Study Arms (3)

Skimmed milk powder

EXPERIMENTAL

One rumen-fistulated Holstein-Friesian dairy cow in high lactation status will be given 0.6 L deuteriated water 3 times per day for 3 days long. Milk collection will take place twice a day on the fourth and fifth day. Milk will be processed into skimmed milk powder.

Other: Milk

Sorghum whole grain

EXPERIMENTAL

Sorghum plants are grown in the greenhouse. Those receive deuteriated water for five days with one day in between. On the first day the water has a 25% dilution and the other four days the water has a 5% dilution.

Other: Sorghum

Black beans

EXPERIMENTAL

Black bean plants are grown in the greenhouse. Those receive deuteriated water for five days with one day in between. On the first day the water has a 25% dilution and the other four days the water has a 5% dilution.

Other: Black beans

Interventions

Milk OTHER

Twenty grams of the deuterium (2H) - labelled skimmed milk powder mixed with water will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference. Protein free cookies are served alongside to equal macronutrient composition with the other two protein sources.

Skimmed milk powder

Sorghum OTHER

Twenty grams of the deuterium (2H) - labelled whole grain sorghum cooked with water will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference.

Sorghum whole grain

Black beans OTHER

Twenty grams of the deuterium (2H) - labelled black beans cooked with water and mashed into a puree, will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference. A carbohydrate drink is served alongside to equal macronutrient composition with the other two protein sources.

Black beans

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-35 years or 65-80 years
• Body Mass Index (BMI): 20.0 - 30.0 kg/m2
• Veins suitable for blood sampling
• Healthy as assessed with a questionnaire
• Regular and normal Dutch eating habits as assessed with a questionnaire
• 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.

You may not qualify if:

• Chronic disease, for example:
• Diabetes mellitus, being treated for high blood glucose or increased fasting blood glucose (\> 6.7 mmol/l in finger prick blood)
• Active cardiovascular disease
• Hepatic disease (e.g. hepatitis)
• Renal disease
• Cancer
• Bowel disease (e.g. inflammatory bowel disease, ulcers, bleeding)
• Pancreatitis
• History of medical or surgical events that may affect GI function and the study outcomes, for example:
• Bariatric surgery
• Gastrointestinal tract surgery
• Digestive tract disorder
• Chewing problems
• Medicine use that interferes with GI function and the study outcomes, for example:
• Glucose lowering drugs

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708 WE, Netherlands

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. MR (Marco) Mensink

Model Details: Participants will have three test days, each separated by two weeks. The participants will randomly consume one of the three protein sources on each test day respectively.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: September 9, 2022
• Study Start: September 27, 2022
• Primary Completion: March 31, 2023
• Study Completion: September 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

NL (1)