Biological AgingNCT03213340
Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding
A study testing Catechin Cohort 1, Curcuminoid Cohort 2 and Flavonoid Cohort 3 in people with Biological Aging, run by Abbott Nutrition at 1 site in United Kingdom.
Trial summary
This is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biological Aging
- What is being tested?
- Catechin Cohort 1, Curcuminoid Cohort 2 and Flavonoid Cohort 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2017to 2 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Body mass index (BMI) 18-30 kg/m2
- Free from active metabolic disease
- Normotensive
Who cannot join
- Habitual gym use or formal exercise (more than once a week) or other routine strenuous physical activity
- Smokers
- Surgery within past 3 months
- Active cardiovascular disease
- Taking beta-adrenergic blocking agents
- Cerebrovascular disease:
Show all 17Show fewer
- Active respiratory disease
- Active metabolic disease
- Active inflammatory bowel or renal disease
- Active Malignancy or until confirmed remission
- Clotting dysfunction
- History of DVT
- Significant musculoskeletal or neurological disorders
- Family history of early (<55y) death from cardiovascular disease
- Known sensitivity to Sonovue contrast agent
- Known allergy or intolerance to any of the study ingredients
- Current use of any of the study ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Explore the Acute Effects of Phytonutrients Upon Muscle Microvascular Blood Flow (Perfusion) in Response to Feeding in Older Adults.
This is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus.
- Conditions
- Biological Aging
- Being tested
- Catechin Cohort 1, Curcuminoid Cohort 2, Flavonoid Cohort 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catechin Cohort 1Other
- 4 capsules taken with water 1 hour prior to meal
Curcuminoid Cohort 2Other
- 2 capsules taken with water 1 hour prior to meal
Flavonoid Cohort 3Other
- ~ 1 oz. serving consumed 30 minutes before meal
| Study group | Role | What they receive |
|---|---|---|
| Catechin Cohort 1 | Experimental | 2 treatment - Experimental Catechin Blend; Control 1 Placebo Receives: Other: Catechin Cohort 1 |
| Curcuminoid Cohort 2 | Experimental | 2 treatment - Experimental Curcuminoid Blend; Control 1 Placebo Receives: Other: Curcuminoid Cohort 2 |
| Flavonoid Cohort 3 | Experimental | 2 treatment - Experimental Flavonoid Blend; Control 2 Low-Flavonoid Blend Receives: Other: Flavonoid Cohort 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle microvascular blood flow
contrast enhanced ultrasound
Measured: Baseline to 240 minutes
Secondary outcomes (4)
muscle macrovascular blood flow
doppler ultrasound
Measured: Baseline to 240 minutes
central vascular blood flow
echocardiography
Measured: Baseline to 90 minutes
cerebral blood flow
doppler ultrasound
Measured: Baseline to 120 minutes
endothelial function
flow mediated dilation
Measured: Baseline to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start14 Sep 2017
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AgingStudies of the same condition, open and under way.
- 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
- 3 cohorts, crossover within cohort
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzette Pereira, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213340
- Sponsor's protocol ID
- BL31
- Status last verified
- Jan 2020
- First submitted
- 26 Jun 2017
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore the Acute Effects of Phytonutrients Upon Muscle Microvascular Blood Flow (Perfusion) in Response to Feeding in Older Adults.
- ClinicalTrials.gov ID
- NCT03213340
- Acronym / sponsor ID
- BL31
- Conditions
- Biological Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 cohorts, crossover within cohort
| Arm | Type | Receives |
|---|---|---|
| Catechin Cohort 1 | Experimental | Other: Catechin Cohort 12 treatment - Experimental Catechin Blend; Control 1 Placebo |
| Curcuminoid Cohort 2 | Experimental | Other: Curcuminoid Cohort 22 treatment - Experimental Curcuminoid Blend; Control 1 Placebo |
| Flavonoid Cohort 3 | Experimental | Other: Flavonoid Cohort 32 treatment - Experimental Flavonoid Blend; Control 2 Low-Flavonoid Blend |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 18-30 kg/m2
- Free from active metabolic disease
- Normotensive
Key exclusion criteria (17 listed)
- Habitual gym use or formal exercise (more than once a week) or other routine strenuous physical activity
- Smokers
- Surgery within past 3 months
- Active cardiovascular disease
- Taking beta-adrenergic blocking agents
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 |
|---|---|---|
| Catechin Cohort 1- 4 capsules taken with water 1 hour prior to meal | Other | Catechin Cohort 1 |
| Curcuminoid Cohort 2- 2 capsules taken with water 1 hour prior to meal | Other | Curcuminoid Cohort 2 |
| Flavonoid Cohort 3- ~ 1 oz. serving consumed 30 minutes before meal | Other | Flavonoid Cohort 3 |
Primary outcome
muscle microvascular blood flow
Time frame: Baseline to 240 minutes
contrast enhanced ultrasound
4 secondary outcomes
muscle macrovascular blood flow
Time frame: Baseline to 240 minutes
central vascular blood flow
Time frame: Baseline to 90 minutes
cerebral blood flow
Time frame: Baseline to 120 minutes
endothelial function
Time frame: Baseline to 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- 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.
Suzette Pereira, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catechin Cohort 1, Curcuminoid Cohort 2 and Flavonoid Cohort 3 in people with Biological Aging, run by Abbott Nutrition at 1 site in United Kingdom.
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 3 inclusion and 17 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 31 Jan 2020. 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 Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
muscle microvascular blood flow (time frame: Baseline to 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.