Clinical trial NCT04356573: (KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit
Official title: (KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Protein
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects crossed over between ingesting 2 different types of kiwifruit for 2 weeks prior to each stable isotope metabolic study.
Primary purpose: OTHER

Brief summary: The specific hypothesis is that the consumption of 2 Hayward green kiwifruit (containing actinidin protease) prior to 100g of ground beef will increase the rate of protein digestion from the beef in the elderly, leading to an increased uptake of the essential amino acids. Furthermore, this increased essential amino acid availability will produce a greater postprandial net anabolic protein response, as well as increased fractional synthetic rates of muscle proteins.

Detailed description: The specific hypothesis is that the consumption of 2 Hayward green kiwifruit (containing actinidin protease) prior to 100g of ground beef will increase the rate of protein digestion from the beef in the elderly, leading to an increased uptake of the essential amino acids. Furthermore, this increased essential amino acid availability will produce a greater postprandial net anabolic protein response, as well as increased fractional synthetic rates of muscle proteins.

To test this hypothesis, the investigators will use a double-blinded crossover design involving two intervention arms; in both arms 100g of ground beef (cooked weight) will be consumed following either 2 Hayward green kiwifruit (containing actinidin protease) or 2 Hort16A Gold kiwifruit (devoid of actinidin protease) by elderly subjects.

Eligibility criteria: Inclusion Criteria:

* men and women ages 60-85 inclusive.

Exclusion Criteria:

* Inability to chew meats or difficulty swallowing solid foods
* History of diabetes
* History of malignancy in the 6 months prior to enrolment
* History of gastrointestinal reduction or bypass surgery (Lapband, etc)
* History of a chronic inflammatory condition or disease (Lupus, HIV'AIDS, etc)
* History of chronic kidney disease or currently requiring dialysis.
* Allergy to beef or kiwifruit
* Subjects who do not or will not eat animal proteins
* Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
* Subjects who report regular resistance exercise (more than once per week)
* Hemoglobin less than 9.5mg/dL at the screening visit
* Platelets less than \<150,000 at the screening visit
* Subjects who are not willing or able to suspend aspirin for several days prior to their muscle biopsies.
* Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox, heparin, Plavix, etc).
* Concomitant use of corticosteroids (ingestion, injection or transdermal)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Primary outcomes:
measure: Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)
timeFrame: 300 minutes
Secondary outcomes:
measure: Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)
timeFrame: 9.5 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Center on Aging
state: Arkansas
Study officials:
affiliation: UAMS professor
name: Arny A Ferrando, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park S, Church DD, Starck C, Schutzler SE, Azhar G, Kim IY, Ferrando AA, Moughan PJ, Wolfe RR. The impact of Hayward green kiwifruit on dietary protein digestion and protein metabolism. Eur J Nutr. 2021 Mar;60(2):1141-1148. doi: 10.1007/s00394-020-02363-5. Epub 2020 Sep 24.