NCT04356573

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

Completed NA Results posted Last updated 4 November 2021

What this trial tests

NA trial testing Green Hayward Kiwifruit first, then Gold Kiwifruit in Metabolism in 13 participants. Completed in 20 November 2018.

Timeline

1 July 2018

Primary endpoint
20 November 2018

20 November 2018

Quick facts

Lead sponsor	University of Arkansas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	13
Start date	1 July 2018
Primary completion	20 November 2018
Estimated completion	20 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Green Hayward Kiwifruit first, then Gold Kiwifruit
• Gold Kiwifruit First, then Green Hayward Kiwifruit

Conditions studied

• Metabolism — all drugs for Metabolism →
• Protein — all drugs for Protein →

Sponsor

University of Arkansas

Who can join

Adults 60 to 85, any sex, with Metabolism or Protein. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS) Primary · 300 minutes

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

Group	Value	95% CI
Gold Kiwifruit	14.58	± 4.31
Green Hayward Kiwifruit	14.55	± 3.24

Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS) Secondary · 9.5 hours

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.

Group	Value	95% CI
Gold Kiwifruit	0.0043	± 0.0244
Green Hayward Kiwifruit	0.0081	± 0.0393

Adverse events — posted to ClinicalTrials.gov

Time frame: While subjects were enrolled in the study; up to two months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gold Kiwifruit

Serious: 0/12 (0%)

Deaths: 0/12

Green Hayward Kiwifruit

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (1 terms — click to expand)

Reaction	System	Gold Kiwifruit	Green Hayward Kiwifruit
Viral Bronchitis	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04356573 adverse events section.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The impact of Hayward green kiwifruit on dietary protein digestion and protein metabolism.
   Park S, Church DD, Starck C, Schutzler SE, et al · · 2021 · cited 10× · PMID 32970234 · DOI 10.1007/s00394-020-02363-5