Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

January 29, 2020 updated by: Abbott Nutrition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE22 3DT
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle macrovascular blood flow
Time Frame: Baseline to 240 minutes
doppler ultrasound
Baseline to 240 minutes
central vascular blood flow
Time Frame: Baseline to 90 minutes
echocardiography
Baseline to 90 minutes
cerebral blood flow
Time Frame: Baseline to 120 minutes
doppler ultrasound
Baseline to 120 minutes
endothelial function
Time Frame: Baseline to 120 minutes
flow mediated dilation
Baseline to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Suzette Pereira, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

October 2, 2019

Study Completion (Actual)

October 2, 2019

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BL31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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