(KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit

Metabolism Clinical Trial

Official title:

(KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356573
• Other study ID #: 206814
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: October 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism
• Protein

Intervention

Dietary Supplement:
• Green Hayward Kiwifruit first, then Gold Kiwifruit
Subjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing.
• Gold Kiwifruit First, then Green Hayward Kiwifruit
Subjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing.

Locations

Country	Name	City	State
United States	UAMS Center on Aging	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)	Blood samples were analyzed to quantify the appearance of the stable isotopes: 2H2-tyrosine, 2H4-tyrosine, and 2H5-phenylalanine in tracer to tracee ratio or mole percent excess. Changes in these markers over time enable the calculation of whole body protein metabolism. Calculations are done as follows: Total plasma rate of appearance = infusion rate/enrichment Fractional rate of appearance of tyrosine from phenylalanine= 2H4-tyrosine/2H5-phenylalanine Phenylalanine hydroxylation = fractional rate of appearance of tyrosine from phenylalanine x rate of appearance of tyrosine Protein Synthesis = [(rate of appearance of phenylalanine -Phe hydroxylation) x 25] Protein Breakdown = [(rate of appearance of phenylalanine - phenylalanine infusion rate) x 25 - phenylalanine intake] Net Balance = Protein Synthesis - Protein Breakdown	300 minutes
Secondary	Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)	Muscle samples were analyzed to quantify the appearance of the stable isotope 2H5-phenylalanine in trace to tracee ratio or mole percent excess. The change in 2H5-phenylalanine in subsequent muscle biopsy allow for the calculation of muscle protein synthesis. The calculation is done as follows: [(2H5-phenylalanine enrichment in second biopsy - 2H5-phenylalanine enrichment in second biopsy)/ (2H5-phenylalanine plasma enrichment × time)] × 60 × 100.	9.5 hours