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

NCT04356573 | Completed Results

• 1 other identifier: 206814
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism; Protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)

  9.5 hours

Study Arms (2)

Gold Kiwifruit First, then Green Hayward Kiwifruit

PLACEBO COMPARATOR

Subjects first ate 2 gold kiwifruit with midday meal for 2 weeks before crossing over to the green Hayward kiwifruit intervention

Dietary Supplement: Green Hayward Kiwifruit first, then Gold Kiwifruit; Dietary Supplement: Gold Kiwifruit First, then Green Hayward Kiwifruit

Green Hayward Kiwifruit first, then Gold Kiwifruit

ACTIVE COMPARATOR

Subjects first ate 2 green Hayward kiwifruit with midday meal for 2 weeks before crossing over to the gold kiwifruit intervention

Dietary Supplement: Green Hayward Kiwifruit first, then Gold Kiwifruit; Dietary Supplement: Gold Kiwifruit First, then Green Hayward Kiwifruit

Interventions

Green Hayward Kiwifruit first, then Gold Kiwifruit DIETARY_SUPPLEMENT

Subjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing.

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

Gold Kiwifruit First, then Green Hayward Kiwifruit DIETARY_SUPPLEMENT

Subjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing.

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women ages 60-85 inclusive.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Center on Aging

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 32970234 DERIVED

Results Point of Contact

• Title: Robert Wolfe
• Organization: UAMS

rrwolfe2@uams.edu

501-526-5708

Study Officials

• Arny A Ferrando, Ph.D.

  UAMS professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Biological samples were coded and code list password protected until all data was analyzed.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects crossed over between ingesting 2 different types of kiwifruit for 2 weeks prior to each stable isotope metabolic study.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: July 1, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)