Bioavailability of Carotenoids Added Into Processed Foods

NCT02246985 | Completed

• 1 other identifier: 14/HSMC/2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiovascular Disease

Keywords

Processed foods; Carotenoids in plasma, urine and faeces; alpha-carotene; beta-carotene; Vitamin A; Lycopene; Gut absorption; Bread; Mayonnaise; Bioavailability; Fruits and Vegetables; Inflammation; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction

  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 Outcomes (1)

• Change in carotenoid concentration in urine

  at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal

Other Outcomes (3)

• Measurement of plasma retinol and retinyl ester concentrations

  at baseline and at every hour for up to 8 hours post-prandial and at 24 hours after the test meal

• Plasma cholesterol concentrations

  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

  immediately before and after consumption of test meals

Study Arms (4)

Plain bread with plain mayonnaise

EXPERIMENTAL

Control meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids

Dietary Supplement: Control

Vegetable bread only

EXPERIMENTAL

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

Dietary Supplement: Vegetable bread only

Vegetable bread with plain mayonnaise

EXPERIMENTAL

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.

Dietary Supplement: Vegetable bread with plain mayonnaise

Plain bread with vegetable mayonnaise

EXPERIMENTAL

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.

Dietary Supplement: Plain bread with vegetable mayonnaise

Interventions

Control DIETARY_SUPPLEMENT

The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.

Also known as: plain bread with plain mayonnaise

Plain bread with plain mayonnaise

Vegetable bread only DIETARY_SUPPLEMENT

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.

Vegetable bread only

Plain bread with vegetable mayonnaise DIETARY_SUPPLEMENT

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 with vegetable mayonnaise

Vegetable bread with plain mayonnaise DIETARY_SUPPLEMENT

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

Vegetable bread with plain mayonnaise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute of Nutrition and Health, Human Nutrition Unit

Aberdeen, AB21 9SB, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Viren Ranawana, Msc, PhD

  Rowett Institute of Nutrition & Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 27, 2017

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)