NCT02169661

Brief Summary

Consumption of "ready meals" and other convenience foods are rapidly increasing. However, their nutritional value is problematical. For example, many are high in fats which are potentially oxidisable resulting in the formation of toxic end products. Consequently the aim of this study is to assess whether consumption of "ready meals" rich in certain fats leads to a post-prandial increase in lipid oxidation products in plasma and whether this can be ameliorated by reformulating the meals with natural extracts rich in phytochemicals with potential antioxidant activity in the stomach

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

1.4 years

First QC Date

July 26, 2011

Last Update Submit

June 20, 2014

Conditions

Oxidative Stress

Keywords

Oxidative stressLipid peroxidesPhytochemicalsReady mealsBeetrootBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Lipid peroxides

    Indices of oxidised lipids in plasma

    up to 24 hours

Secondary Outcomes (1)

  • Blood pressure

    up to 24 hours

Study Arms (1)

Burger and Beetroot Study

EXPERIMENTAL
Other: Burger and Beetroot Study

Interventions

Burger and Beetroot StudyOTHER

50% fat, 10% beetroot extract

Burger and Beetroot Study

Eligibility Criteria

Age21 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No diagnosed clinical condition

You may not qualify if:

  • Are taking any medicines prescribed by their GP Have a known allergy to beetroot Are vegan Regularly take nutritional supplements Have given a large blood donation in last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Unit, Rowett Institute of Nutrition and Health

Aberdeen, Scotland, AB21 9SB, United Kingdom

Location

Study Officials

  • Garry G Duthie, PhD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

June 23, 2014

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

GB(1)