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Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

Sponsor
Abbott Nutrition (Industry)
Overall Status
Completed
CT.gov ID
NCT03213340
Collaborator
(none)
39
Enrollment
1
Location
3
Arms
24.6
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Catechin Cohort 1
  • Other: Curcuminoid Cohort 2
  • Other: Flavonoid Cohort 3
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
3 cohorts, crossover within cohort3 cohorts, crossover within cohort
Masking:
Single (Participant)
Primary Purpose:
Other
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.
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Oct 2, 2019
Actual Study Completion Date :
Oct 2, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Catechin Cohort 1

2 treatment - Experimental Catechin Blend; Control 1 Placebo

Other: Catechin Cohort 1
- 4 capsules taken with water 1 hour prior to meal
Experimental: Curcuminoid Cohort 2

2 treatment - Experimental Curcuminoid Blend; Control 1 Placebo

Other: Curcuminoid Cohort 2
- 2 capsules taken with water 1 hour prior to meal
Experimental: Flavonoid Cohort 3

2 treatment - Experimental Flavonoid Blend; Control 2 Low-Flavonoid Blend

Other: Flavonoid Cohort 3
- ~ 1 oz. serving consumed 30 minutes before meal

Outcome Measures

Primary Outcome Measures

  1. muscle microvascular blood flow [Baseline to 240 minutes]

    contrast enhanced ultrasound

Secondary Outcome Measures

  1. muscle macrovascular blood flow [Baseline to 240 minutes]

    doppler ultrasound

  2. central vascular blood flow [Baseline to 90 minutes]

    echocardiography

  3. cerebral blood flow [Baseline to 120 minutes]

    doppler ultrasound

  4. endothelial function [Baseline to 120 minutes]

    flow mediated dilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nottingham Derby United Kingdom DE22 3DT

Sponsors and Collaborators

  • Abbott Nutrition

Investigators

  • Study Chair: Suzette Pereira, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT03213340
Other Study ID Numbers:
  • BL31
First Posted:
Jul 11, 2017
Last Update Posted:
Jan 31, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 31, 2020