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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04356573
Enrollment
13
Registered
2020-04-22
Start date
2018-07-01
Completion date
2018-11-20
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism, Protein

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.

Interventions

DIETARY_SUPPLEMENTGreen Hayward Kiwifruit first, then Gold Kiwifruit

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

DIETARY_SUPPLEMENTGold Kiwifruit First, then Green Hayward Kiwifruit

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

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Biological samples were coded and code list password protected until all data was analyzed.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)300 minutesBlood 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

Secondary

MeasureTime frameDescription
Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)9.5 hoursMuscle 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.

Countries

United States

Participant flow

Pre-assignment details

Protocol enrollment was 13 participants, each was to complete 2 conditions in crossover fashion (i.e., either green kiwi followed by yellow kiwi, or yellow kiwi followed by green kiwi). One subject dropped out, which left 6 subjects in each group.

Participants by arm

ArmCount
Gold Kiwifruit First, Then Green Hayward Kiwifruit
Subjects were first asked to eat 2 gold kiwifruit with midday meal for 14 days prior to testing. Then a washout for 14 days. Then, subjects were asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to a second set of testing.
6
Green Hayward Kiwifruit First, Then Gold Kiwifruit
Subjects were first asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to testing. Then a washout for 14 days. Then, subjects were asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to a second set of testing.
6
Total12

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDidn't Qualify10

Baseline characteristics

CharacteristicGreen Hayward Kiwifruit First, Then Gold KiwifruitTotalGold Kiwifruit First, Then Green Hayward Kiwifruit
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants10 Participants4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants2 Participants2 Participants
Age, Continuous72.1 years
STANDARD_DEVIATION 6.2
72.1 years
STANDARD_DEVIATION 6.2
72.1 years
STANDARD_DEVIATION 6.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants10 Participants4 Participants
Region of Enrollment
United States
6 participants12 participants6 participants
Sex: Female, Male
Female
4 Participants6 Participants2 Participants
Sex: Female, Male
Male
2 Participants6 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
1 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

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

Time frame: 300 minutes

ArmMeasureValue (MEAN)Dispersion
Gold KiwifruitWhole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)14.58 g protein per 300 minsStandard Deviation 4.31
Green Hayward KiwifruitWhole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)14.55 g protein per 300 minsStandard Deviation 3.24
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.

Time frame: 9.5 hours

ArmMeasureValue (MEAN)Dispersion
Gold KiwifruitChange in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)0.0043 % per hourStandard Deviation 0.0244
Green Hayward KiwifruitChange in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)0.0081 % per hourStandard Deviation 0.0393
p-value: 0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026