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CompletedNCT02169661BABSUpdated Jun 23, 2014

Burger and Beetroot Study - Lipid Oxidation Study

An interventional study of Burger and Beetroot Study in Oxidative Stress, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Open to male participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-23.

Sponsored by University of Aberdeen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
21 Years to 60 Years
Sex
Male
01

Study 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

Read the detailed description

Many of these lipid oxidation products such as malondialdehyde are known to be genotoxic and potentially detrimental to health. 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.

Diet design requirements:

The basic "ready meal" is a turkey burger consisting of

  • 50% fat
  • 20% protein
  • 30% carbohydrate.

However, there are four experimental forms of the burger.

  1. The fat is unsaturated (stripped corn oil)
  2. The fat is saturated (lard)
  3. The fat is unsaturated and the diet also contains a beetroot extract at a concentration of 10g/100g.
  4. The fat is saturated and the diet also contains a beetroot extract at a concentration of 10g/100g.

Beetroot (http://www.kanegrade.com/powders.htm) has been selected for the burger reformulation as it is a Scottish product rich in phytochemicals with potential antioxidant efficacy. An additional benefit may a blood pressure lowering effect. Initial taste tests indicate acceptable palatability.

All other components of the burger are formulated to be as similar as possible.

Fatty acid profiles and the "basic eight" used on food labels will be determined on the diets. Susceptibility of the diets to oxidise will be assessed using RANCIMAT.

Ready Meal Intervention:

This will be a latin square format whereby each volunteer consumes 4 treatments on separate occasions. This is a powerful design to assess whether incorporation of phytochemicals from Scottish products improves the health benefits of processed food as each volunteer acts as his/her own control. Volunteers will be randomly allocated to four groups

  • Treatment A High polyunsaturated (PUFA) ready meal (ie. burger)
  • Treatment B High saturated (SFA) fat ready meal
  • Treatment C High PUFA ready meal incorporating food extract
  • Treatment D High SFA ready meal incorporating food extract

There will be a washout period of at least 7 days between each treatment.

Volunteers:

Healthy volunteers aged 21 to 60 years will be recruited and attend HNU having fasted from 22.00h the previous evening on four test days. On arrival, they will be asked to provide a urine sample. The volunteers will then have a cannula inserted by a trained nurse and an initial baseline blood sample will be taken (volume 10 ml). The subjects will then be asked to consume the assigned breakfast within a 15 minute period. Water will be provided. Volunteers will then be requested to provide 10ml blood samples at 1h, 2h, 4h and 6h and 24 hrs. A 24 hr urine sample also will be obtained, starting the day of the test day. Blood pressure will be recorded at each time point.

Volunteers will not be included if they

  • Are taking any medicines prescribed by their GP
  • Have a known allergy to beetroot
  • Are vegetarian or vegan
  • Regularly take nutritional supplements
  • Have given a large blood donation in last three months
02

Conditions studied

  • Oxidative Stress

Keywords

  • Oxidative stress
  • Lipid peroxides
  • Phytochemicals
  • Ready meals
  • Beetroot
  • Blood pressure
03

In context

Lead sponsor

University of Aberdeen is the lead sponsor of 170 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • No diagnosed clinical condition

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Burger and Beetroot Study

    Other: Burger and Beetroot Study

Interventions

  • OtherBurger and Beetroot Study

    50% fat, 10% beetroot extract

06

What researchers measure

Primary outcomes

  1. Lipid peroxides

    Indices of oxidised lipids in plasma

    Time frame: up to 24 hours

Secondary outcomes

  1. Blood pressure

    Systolic and diastolic blood pressure

    Time frame: up to 24 hours

07

Study locations

1 site
  • Human Nutrition Unit, Rowett Institute of Nutrition and Health
    Aberdeen, Scotland AB21 9SB, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02169661
Lead sponsor
University of Aberdeen
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Jul 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jun 23, 2014

Study contacts

Garry G Duthie, PhD
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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