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

October 7, 2021 updated by: University of Arkansas
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

13

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

    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • UAMS Center on Aging

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

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Gold Kiwifruit First, then Green Hayward Kiwifruit
Subjects first ate 2 gold kiwifruit with midday meal for 2 weeks before crossing over to the green Hayward kiwifruit intervention
Subjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing.
Subjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing.
Active Comparator: Green Hayward Kiwifruit first, then Gold Kiwifruit
Subjects first ate 2 green Hayward kiwifruit with midday meal for 2 weeks before crossing over to the gold kiwifruit intervention
Subjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing.
Subjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)
Time Frame: 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 = [(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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)
Time Frame: 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.
9.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arny A Ferrando, Ph.D., UAMS professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

July 1, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 206814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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