MetabolismNCT04356573
(KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit
A study testing Green Hayward Kiwifruit first, then Gold Kiwifruit and Gold Kiwifruit First, then Green Hayward Kiwifruit in people with Metabolism and Protein, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Protein
- What is being tested?
- Green Hayward Kiwifruit first, then Gold Kiwifruit and Gold Kiwifruit First, then Green Hayward Kiwifruit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women ages 60-85 inclusive.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metabolism, Protein
- Being tested
- Green Hayward Kiwifruit first, then Gold Kiwifruit, Gold Kiwifruit First, then Green Hayward Kiwifruit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Hayward Kiwifruit first, then Gold KiwifruitDietary supplement
Subjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing.
Gold Kiwifruit First, then Green Hayward KiwifruitDietary supplement
Subjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Green Hayward Kiwifruit first, then Gold Kiwifruit; Dietary Supplement: Gold Kiwifruit First, then Green Hayward Kiwifruit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 300 minutes
Secondary outcomes (1)
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.
Measured: 9.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jul 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects crossed over between ingesting 2 different types of kiwifruit for 2 weeks prior to each stable isotope metabolic study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arny A Ferrando, Ph.D., Principal investigator, UAMS professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356573
- Sponsor's protocol ID
- 206814
- Status last verified
- Oct 2021
- First submitted
- 15 Apr 2020
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32970234
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (KIWI) Speeding up a Slow Protein for Muscle Mass With Hay Kiwifruit
- ClinicalTrials.gov ID
- NCT04356573
- Acronym / sponsor ID
- 206814
- Conditions
- Metabolism, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects crossed over between ingesting 2 different types of kiwifruit for 2 weeks prior to each stable isotope metabolic study.
| Arm | Type | Receives |
|---|---|---|
| Gold Kiwifruit First, then Green Hayward Kiwifruit | Placebo comparator | Dietary Supplement: Green Hayward Kiwifruit first, then Gold Kiwifruit, Dietary Supplement: Gold Kiwifruit First, then Green Hayward KiwifruitSubjects 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 | Dietary Supplement: Green Hayward Kiwifruit first, then Gold Kiwifruit, Dietary Supplement: Gold Kiwifruit First, then Green Hayward KiwifruitSubjects first ate 2 green Hayward kiwifruit with midday meal for 2 weeks before crossing over to the gold kiwifruit intervention |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men and women ages 60-85 inclusive.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Hayward Kiwifruit first, then Gold KiwifruitSubjects ate 2 peeled green kiwifruit with their midday meal for 2 weeks prior to testing. | Dietary supplement | Gold Kiwifruit First, then Green Hayward Kiwifruit, Green Hayward Kiwifruit first, then Gold Kiwifruit |
| Gold Kiwifruit First, then Green Hayward KiwifruitSubjects ate 2 peeled gold kiwifruit with their midday meal for 2 weeks prior to testing. | Dietary supplement | Gold Kiwifruit First, then Green Hayward Kiwifruit, Green Hayward Kiwifruit first, then Gold Kiwifruit |
Primary outcome
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
1 secondary outcome
Change in Skeletal Muscle Protein Metabolism Measured by Gas Chromatography-Mass Spectrometry (GC-MS)
Time frame: 9.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32970234Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arny A Ferrando, Ph.D. principal investigator
UAMS professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Hayward Kiwifruit first, then Gold Kiwifruit and Gold Kiwifruit First, then Green Hayward Kiwifruit in people with Metabolism and Protein, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Body Net Balance Measured by Gas Chromatography-Mass Spectrometry (GC-MS) (time frame: 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04356573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.