- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05534464
Protein Digestibility in Older and Younger Adults (DiGest)
December 19, 2023 updated by: Marco Mensink, Wageningen University
Difference in Digestibility of Three Protein Sources Between Older and Younger Adults as Measured With the Dual Tracer Method
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Older adults should meet their amino acid requirements to prevent development of sarcopenia.
Dietary protein quality is of importance, as determined by amino acid composition and digestibility of the consumed protein.
There is a need to investigate the impact of ageing on amino acid digestibility and thus quality in vivo.
The dual tracer method is an indirect, minimal-invasive method to determine amino acid digestibility in humans.
It is expected that amino acid digestibility decreases with age and that the effect between age groups is greater for poorly digestible protein sources.
In this randomized, cross-over study, the researchers will 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.
Secondary objectives concern the difference in amino acid kinetics between older and younger adults and the association between gut health plasma markers and amino acid digestibility.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WE
- Wageningen University and Research
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- Proton pump inhibitors
- Laxatives
Habits that interfere with the study outcomes:
- Probiotics and/or protein supplement use
- Smoking
- Drug abuse
- Alcohol consumption for men >21 units/week and >4/day and for women >14 units/week and >3/day
- Following a weight-loss diet, medically prescribed diet or other diet with a low calorie intake or an unbalanced nutrient intake like a vegan or very low carbohydrate diet
- Moderate to high intense physical activity for more than 5 hours a week
- Difficulties with eating breakfast in the morning
Other:
- Self-reported allergy or intolerance to the tested products (milk, sorghum, black beans)
- Weight loss of more than 3 kg in the month prior to study screening
- Being pregnant
- For men: Hb <8,5 mmol/l and for women: Hb <7,5 mmol/l
- Recent blood donation (<2 months prior to start of the study)
- Current participation in other research and <2 months previous participation in other research
- 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
- Working at the department of Human Nutrition and Health at Wageningen University & Research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Skimmed milk powder
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.
|
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.
|
Experimental: Sorghum whole grain
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.
|
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.
|
Experimental: Black beans
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amino acid digestibility of three different protein sources
Time Frame: 1 measurement repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
|
Ratio between meal and plasma isotope enrichment in amino acids
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1 measurement repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear increase in plasma amino acids of three different protein sources
Time Frame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
|
Amino acids in plasma are determined over time.
First measure of kinetics is the linear increase or the slope of the curve.
|
11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
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Area under the curve for plasma amino acid concentration of three different protein sources
Time Frame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
|
Amino acids in plasma are determined over time.
Second measure of kinetics is the area under the curve.
|
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
Time Frame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
|
Amino acids in plasma are determined over time.
Third measure of kinetics is the steady state concentration or the plateau of the curve.
|
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
Time Frame: 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
|
Four gut health markers in plasma will be measured: kynurenine/tryptophan ratio, citrulline, ornithine, I-FABP.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
September 7, 2022
First Posted (Actual)
September 9, 2022
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NL80529.091.22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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