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OpenTrials
Completed

NCT Number: NCT03213340

Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

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.

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Key information

Conditions

Biological Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Derby, DE22 3DT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catechin Cohort 1

Other
  • 4 capsules taken with water 1 hour prior to meal

Curcuminoid Cohort 2

Other
  • 2 capsules taken with water 1 hour prior to meal

Flavonoid Cohort 3

Other
  • ~ 1 oz. serving consumed 30 minutes before meal

Primary outcomes

  1. muscle microvascular blood flow

    Time frame: Baseline to 240 minutes

    contrast enhanced ultrasound

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Pilot Study to Explore the Acute Effects of Phytonutrients Upon Muscle Microvascular Blood Flow (Perfusion) in Response to Feeding in Older Adults.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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