Trial Outcomes & Findings for (KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit (NCT NCT04356573)

Last Updated: 2021-11-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

300 minutes

Results posted on

2021-11-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Gold Kiwifruit First, Then Green Hayward Kiwifruit Subjects were first asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to testing. Later, subjects were asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to a second set of testing.	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. Later, subjects were asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to a second set of testing.
Overall Study STARTED	7	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Gold Kiwifruit First, Then Green Hayward Kiwifruit Subjects were first asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to testing. Later, subjects were asked to eat 2 green Hayward kiwifruit with midday meal for 2 weeks prior to a second set of testing.	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. Later, subjects were asked to eat 2 gold kiwifruit with midday meal for 2 weeks prior to a second set of testing.
Overall Study Didn't Qualify	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gold Kiwifruit First, Then Green Hayward Kiwifruit n=6 Participants 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.	Green Hayward Kiwifruit First, Then Gold Kiwifruit n=6 Participants 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.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	72.1 years STANDARD_DEVIATION 6.2 • n=5 Participants	72.1 years STANDARD_DEVIATION 6.2 • n=7 Participants	72.1 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 300 minutes

Outcome measures

Outcome measures
Measure	Gold Kiwifruit n=12 Participants Subjects ate 2 gold kiwifruit with midday meal for 2 weeks. fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing.	Green Hayward Kiwifruit n=12 Participants Subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks. fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing.
Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS)	14.58 g protein per 300 mins Standard Deviation 4.31	14.55 g protein per 300 mins Standard Deviation 3.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gold Kiwifruit n=12 Participants Subjects ate 2 gold kiwifruit with midday meal for 2 weeks. fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing.	Green Hayward Kiwifruit n=12 Participants Subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks. fresh kiwifruit: Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing.
Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)	0.0043 % per hour Standard Deviation 0.0244	0.0081 % per hour Standard Deviation 0.0393

Adverse Events

Gold Kiwifruit

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Green Hayward Kiwifruit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gold Kiwifruit n=12 participants at risk Subjects ate 2 gold kiwifruit with midday meal for 2 weeks. Half of the subjects ate the gold kiwifruit first, half of the subjects ate the gold kiwifruit second; however all subjects ate 2 gold kiwifruit with midday meal for 2 weeks at some point in this study.	Green Hayward Kiwifruit n=12 participants at risk Subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks. Half of the subjects ate the green Hayward kiwifruit first, half of the subjects ate the green Hayward kiwifruits second; however all subjects ate 2 green Hayward kiwifruit with midday meal for 2 weeks at some point in this study.
Infections and infestations Viral Bronchitis	8.3% 1/12 • Number of events 1 • While subjects were enrolled in the study; up to two months.	0.00% 0/12 • While subjects were enrolled in the study; up to two months.

Additional Information

Robert Wolfe

UAMS

Phone: 501-526-5708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place