Bioavailability of Carotenoids Added Into Processed Foods (CAROTFoods)

February 24, 2017 updated by: University of Aberdeen

Bioavailability of Carotenoids Incorporated Into Processed Foods: Bread and Mayonnaise

Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for the human body as precursors of vitamin A. They are also thought to be important as anti-oxidants and may help protect against cancer and heart disease. Although many foods are rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed and available for metabolism in humans.

Devising practical ways and means of increasing carotenoid bioavailability could lead to better health outcomes. Processed foods are now widely eaten by many, both for their taste and convenience. No studies have thus far looked at the bioavailability of carotenoids that have been added into processed foods. Thus the purpose of this study is to investigate the bioavailability of carotenoids that have been incorporated into processed food products (bread and mayonnaise).

Study Overview

Detailed Description

Carotenoids are a diverse group of natural-occurring fat-soluble pigments. Whilst over 600 different types have been characterised around 20 have been found in human tissue in the postprandial state, however, over 90% of these absorbed carotenoids are made up of 6 specific types (alpha-Carotene, beta-carotene, Lycopene, Lutein, Zeaxanthin and Cryptoxanthin)

There is good evidence to suggest that carotenoids play a notable role in human health both through their pro-vitamin activity and as biological antioxidants. Carotenoids are believed to be responsible for the beneficial effects of fruits and vegetables in preventing human chronic diseases such as cancer and cardiovascular disease. Increasing fruit and vegetables intakes in individuals can sometimes be difficult and unsustainable, therefore, increasing bioavailability may be an effective alternative approach to maximise health outcomes.

A notable number of vegetables are rich sources of carotenoids, however, the amounts available to the human body for metabolism are often small due to poor bioavailability. For instance, studies have shown that bioavailability of carotenoids from carrots and tomatoes can be as low as 1-3%. The bioavailability of carotenoids has been shown to depend on factors such as their source, degree of cooking, processing, mechanical breakdown, presence of fat and interactions between carotenoids. Whilst the presence of fat significantly increases carotenoid absorption, the oil type, quantity and form it is in all affect bioavailability.

Recent work suggests that carotenoid bioavailability improves when fat is present in the form of mayonnaise rather than as plain oil. This may be due to the emulsion properties of mayonnaise which allows better solubilisation of amphiphilic compounds such as carotenoids. Mayonnaise has also been shown to be more miscible in gastric juices (compared to plain oil) and this too may be contributing to the greater absorption of carotenoids.

The present study builds upon this previous work and studies carotenoid bioavailability in processed food systems. Using a bread-mayonnaise meal the study compares carotenoid bioavailability when it is incorporated either into the bread or the mayonnaise. Furthermore, the study investigates the impact of mayonnaise on the bioavailability of carotenoids incorporated into a processed food (bread). The study will focus on the bioavailability of three principle carotenoids found in foods, alpha-carotene, beta-carotene and lycopene. Carrot and tomato are used as the sources of carotenoids.

HYPOTHESIS Carotenoid bioavailability is influenced by the food matrix in which they are contained.

OBJECTIVES

  1. To compare the acute-phase bioavailability (systemic and gut absorption) of targeted carotenoids (alpha-carotene, beta-carotene and lycopene) when they are incorporated into the different processed food matrices (bread and mayonnaise)
  2. Study how mayonnaise affects the acute bioavailability of carotenoids incorporated into a processed food.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females Aged between 18 and 75 years. Body mass index between 18.5 - 40 kg/m2. Blood pressure equal to or less than 139/89 mmHG. HbA1C less than or equal to 6.5%. Total blood cholesterol less than 6.0mmol/l

Exclusion Criteria:

  • Suffering from Diabetes, kidney disease, hepatic disease, gout, gastrointestinal disorder, thromboembolic or coagulation disease, hypertension, thyroid disorder or hypercholesterolaemia On prescription medications Orlistat, Digoxin, Anti-arrhythmics, tricyclic anti-depressants, neuroleptics, oral anti-diabetic medication, insulin, anti-inflammatories, anti-pyretics and Statins Allergic/Intolerant to any of the foods in the study Vegetarian or Vegan Restricted eating and/or eating disorders Alcohol and/or substance abuse Regularly take nutritional supplements (once a day) Smoking Poor venous access and veins difficult to cannulate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plain bread with plain mayonnaise
Control meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids
The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.
Other Names:
  • plain bread with plain mayonnaise
Experimental: Vegetable bread only
A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids
A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids.
Experimental: Vegetable bread with plain mayonnaise
A vegetable powder (carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids.
A vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids
Experimental: Plain bread with vegetable mayonnaise
Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.
Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction
Time Frame: At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal
Carotenoids in plasma and in the chylomicron-rich fraction will be measured using reverse-phase HPLC
At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in carotenoid concentration in urine
Time Frame: at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal
Carotenoids in urine will be measured using reverse-phase HPLC
at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of plasma retinol and retinyl ester concentrations
Time Frame: at baseline and at every hour for up to 8 hours post-prandial and at 24 hours after the test meal
Plasma retinol and retinyl ester concentrations will be measured using reverse-phase HPLC
at baseline and at every hour for up to 8 hours post-prandial and at 24 hours after the test meal
Plasma cholesterol concentrations
Time Frame: At baseline and at every hour for up to 8 hours post-prandial and at 24hours after the test meal
Plasma cholesterol concentrations will be measured using reverse-phase HPLC
At baseline and at every hour for up to 8 hours post-prandial and at 24hours after the test meal
Satiety and palatability of test meals
Time Frame: immediately before and after consumption of test meals
Measured using 100mm continuous-line visual analogue scales anchored at each end with opposing answers to satiety and palatability related questions
immediately before and after consumption of test meals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Viren Ranawana, Msc, PhD, Rowett Institute of Nutrition & Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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