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Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03213340
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

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
Biological Aging Other: Catechin Cohort 1 Other: Curcuminoid Cohort 2 Other: Flavonoid Cohort 3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 3 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 : September 14, 2017
Actual Primary Completion Date : October 2, 2019
Actual Study Completion Date : October 2, 2019

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




Primary Outcome Measures :
  1. muscle microvascular blood flow [ Time Frame: Baseline to 240 minutes ]
    contrast enhanced ultrasound


Secondary Outcome Measures :
  1. muscle macrovascular blood flow [ Time Frame: Baseline to 240 minutes ]
    doppler ultrasound

  2. central vascular blood flow [ Time Frame: Baseline to 90 minutes ]
    echocardiography

  3. cerebral blood flow [ Time Frame: Baseline to 120 minutes ]
    doppler ultrasound

  4. endothelial function [ Time Frame: Baseline to 120 minutes ]
    flow mediated dilation



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213340


Locations
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United Kingdom
University of Nottingham
Derby, United Kingdom, DE22 3DT
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Suzette Pereira, PhD Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03213340    
Other Study ID Numbers: BL31
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No