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Burger and Beetroot Study - Lipid Oxidation Study (BABS)

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ClinicalTrials.gov Identifier: NCT02169661
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE July 26, 2011
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date June 23, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Lipid peroxides [ Time Frame: up to 24 hours ]
Indices of oxidised lipids in plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Blood pressure [ Time Frame: up to 24 hours ]
Systolic and diastolic blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Burger and Beetroot Study - Lipid Oxidation Study
Official Title  ICMJE Lipid Oxidation of Ready Meals: Reformulation With Antioxidant Phytochemicals
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Oxidative Stress
Intervention  ICMJE Other: Burger and Beetroot Study
50% fat, 10% beetroot extract
Study Arms  ICMJE Experimental: Burger and Beetroot Study
Intervention: Other: Burger and Beetroot Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2014)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No diagnosed clinical condition

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169661
Other Study ID Numbers  ICMJE HNU 2000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Garry G Duthie, PhD University of Aberdeen
PRS Account University of Aberdeen
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP