Effects of Phytonutrients Upon Muscle Perfusion in Respon... | NCT03213340

Studies
Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

NCT03213340

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Jan 31, 2020Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Biological Aging

Interventions

Catechin Cohort 1
Curcuminoid Cohort 2
Flavonoid Cohort 3

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2017Actual

Primary Completion Date

Oct 2, 2019Actual

Completion Date

Oct 2, 2019Actual

First Submitted Date

Jun 26, 2017

First Submission Date that Met QC Criteria

Jul 7, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2020

Last Update Posted Date

Jan 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catechin Cohort 1	Experimental	2 treatment - Experimental Catechin Blend; Control 1 Placebo	Other: Catechin Cohort 1
Curcuminoid Cohort 2	Experimental	2 treatment - Experimental Curcuminoid Blend; Control 1 Placebo	Other: Curcuminoid Cohort 2
Flavonoid Cohort 3	Experimental	2 treatment - Experimental Flavonoid Blend; Control 2 Low-Flavonoid Blend	Other: Flavonoid Cohort 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catechin Cohort 1	Other	- 4 capsules taken with water 1 hour prior to meal	Catechin Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle microvascular blood flow	contrast enhanced ultrasound	Baseline to 240 minutes

Secondary Outcomes

Measure	Description	Time Frame
muscle macrovascular blood flow	doppler ultrasound	Baseline to 240 minutes
central vascular blood flow	echocardiography	Baseline to 90 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) 18-30 kg/m2
Free from active metabolic disease
Normotensive

Exclusion Criteria:

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:
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suzette Pereira, PhD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nottingham		Derby		DE22 3DT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided