Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding

Biological Aging Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213340
• Other study ID #: BL31
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Biological Aging

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