Clinical trial NCT05534464: Protein Digestibility in Older and Younger Adults
Official title: Difference in Digestibility of Three Protein Sources Between Older and Younger Adults as Measured With the Dual Tracer Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amino acid digestibility of three different protein sources
timeFrame: 1 measurement repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
Secondary outcomes:
measure: Linear increase in plasma amino acids of three different protein sources
timeFrame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
measure: Area under the curve for plasma amino acid concentration of three different protein sources
timeFrame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
measure: Steady state plasma amino acid concentration of three different protein sources
timeFrame: 11 blood samples during 8 hours, repeated on 3 test days for 3 protein sources respectively, separated by 2 weeks wash-out
measure: Plasma gut health markers of the participants in relation to age and amino acid digestibility
timeFrame: 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
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
References: