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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arny A Ferrando, Ph.D. | UAMS professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Center on Aging | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32970234 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
12 participants completed both crossover conditions. 1 individual failed screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | g protein per 300 mins | 300 minutes |
|
While subjects were enrolled in the study; up to two months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gold Kiwifruit | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Bronchitis | Infections and infestations | Non-systematic Assessment | Event unrelated to study treatments/arms. Subject told staff she was diagnosed with viral bronchitis on Oct. 24th. Treated with abx on 11/9/18. Nearly resolved as of 11/20/18. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Wolfe | UAMS | 501-526-5708 | rrwolfe2@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2018 | Aug 31, 2021 | Prot_SAP_001.pdf |
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Subjects crossed over between ingesting 2 different types of kiwifruit for 2 weeks prior to each stable isotope metabolic study.
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Biological samples were coded and code list password protected until all data was analyzed.
| 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. |
|
| 9.5 hours |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
| OG001 | Green Hayward Kiwifruit | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | % per hour | 9.5 hours |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Green Hayward Kiwifruit | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
|
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