Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding
A Pilot Study to Explore the Acute Effects of Phytonutrients Upon Muscle Microvascular Blood Flow (Perfusion) in Response to Feeding in Older Adults.
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2019
CompletedJanuary 31, 2020
January 1, 2020
2 years
June 26, 2017
January 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
muscle microvascular blood flow
contrast enhanced ultrasound
Baseline to 240 minutes
Secondary Outcomes (4)
muscle macrovascular blood flow
Baseline to 240 minutes
central vascular blood flow
Baseline to 90 minutes
cerebral blood flow
Baseline to 120 minutes
endothelial function
Baseline to 120 minutes
Study Arms (3)
Catechin Cohort 1
EXPERIMENTAL2 treatment - Experimental Catechin Blend; Control 1 Placebo
Curcuminoid Cohort 2
EXPERIMENTAL2 treatment - Experimental Curcuminoid Blend; Control 1 Placebo
Flavonoid Cohort 3
EXPERIMENTAL2 treatment - Experimental Flavonoid Blend; Control 2 Low-Flavonoid Blend
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) 18-30 kg/m2
- Free from active metabolic disease
- Normotensive
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
University of Nottingham
Derby, DE22 3DT, United Kingdom
Study Officials
- STUDY CHAIR
Suzette Pereira, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2017
First Posted
July 11, 2017
Study Start
September 14, 2017
Primary Completion
October 2, 2019
Study Completion
October 2, 2019
Last Updated
January 31, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share