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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03213340
Other study ID # BL31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date October 2, 2019

Study information

Verified date January 2020
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 2, 2019
Est. primary completion date October 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Catechin Cohort 1
- 4 capsules taken with water 1 hour prior to meal
Curcuminoid Cohort 2
- 2 capsules taken with water 1 hour prior to meal
Flavonoid Cohort 3
- ~ 1 oz. serving consumed 30 minutes before meal

Locations

Country Name City State
United Kingdom University of Nottingham Derby

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary muscle microvascular blood flow contrast enhanced ultrasound Baseline to 240 minutes
Secondary muscle macrovascular blood flow doppler ultrasound Baseline to 240 minutes
Secondary central vascular blood flow echocardiography Baseline to 90 minutes
Secondary cerebral blood flow doppler ultrasound Baseline to 120 minutes
Secondary endothelial function flow mediated dilation Baseline to 120 minutes
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