Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/08/2011
Date assigned
14/09/2011
Last edited
08/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Antioxidants are substances that may prevent or delay some types of cell damage (oxidative stress). The human diet provides a wide range of plant-derived phenolics with antioxidant effects. The body’s response to antioxidant-rich foods is determined by the bioavailability of the active molecules - the proportion which enters the circulation and so is able to have an active effect. However, phenolics are generally consumed in foods along with other nutrients such as proteins, fats and sugars. These nutrients may have an impact on the phenolics’ bioavailability. In many countries, polyphenol-rich food like tea or fruit juice is usually consumed with milk. Although there still some discrepancies, many researchers have reported milk reduces the phenolics’ bioavailability. However, the effect of the different components in milk on phenolics’ bioavailability is not known. The aim of this study is to examine the role of different milk components (protein, lipid, lactose) on the phenolics’ bioavailability.

Who can participate?
Healthy volunteers aged 18 - 65

What does the study involve?
Participants are asked to consume their regular diet while avoiding foods rich in polyphenols for 2 days before each study day. These foods include fruit, vegetables, high fibre products, and drinks such as tea, coffee, fruit juice and wine. On five different study days (with a 1-week break between them), participants are randomly allocated to one of five treatments: (a) jujube fruits and water; (b) jujube fruits and whole milk; (c) jujube fruits and skimmed milk; (d) jujube fruits and cream; (e) whole milk and water. Blood samples are collected from all participants 1, 2, 3, 4, 6, 8 hours later. Urine is collected 24 hours before each study day and over five time periods (0–2, 2–5, 5–8, 8-12 and 12–24 hours) after the drinks.

What are the possible benefits and risks of participating?
The results will show whether milk components affect the bioavailability of phenolics. There are no known risks to participants.

Where is the study run from?
China Agricultural University (China)

When is the study starting and how long is it expected to run for?
September 2011 to October 2011

Who is funding the study?
National Science and Technology Support Program (China)

Who is the main contact?
Prof. Fazheng Ren
renfazheng@263.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fazheng Ren

ORCID ID

Contact details

17 Tsing Hua East Road
HaiDian District
Beijing
100083
China
-
renfazheng@263.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of different components in milk on bioavailability of phenolic acid in humans: a randomised crossover interventional study

Acronym

Study hypothesis

The presence of fat in milk will offer more locations for protein linking with phenolics. It means that the effect of cream on phenolics bioavailability is through the presence of mik protein. Accordingly, the phenolics increase fat globule size during digestion will affect the lipid absorption. Furthermore, the effect of lactose and ion in milk on phenolics bioavailability in vivo is not yet evaluated.

Ethics approval

Not provided at time of registration

Study design

Randomised crossover feeding intervention study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Nutrition

Intervention

The acute effects were assessed and compared on five different days (with a 1-week interval between them), using a Latin-square design. The participants were asked to consume their regular diet while avoiding foods rich in polyphenols for 2 days before each study day. These foods included fruit, vegetables, high fibre products, beverages such as tea, coffee, fruit juice and wine. On each study day, the participants arrived at 9am after an overnight fast. Baseline blood was sampled and then participants were randomly assigned to one of five treatments.

Treatments included:
1. 200g jujube fruits and 200ml water
2. 200g jujube fruits and 200ml whole milk
3. 200g jujube fruits and 200ml skimmed milk
4. 200g jujube fruits and 200ml cream
5. 200ml whole milk and 200ml water

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Phenolic acids in plasma and urine measured at 1, 2, 3, 4, 6, 8 hours after intervention

Secondary outcome measures

1. Serum triacylglycerols, total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol
2. Total antioxidant capacity in plasma
3. Resistance of serum lipids to oxidation
The outcomes will be measured at 1, 2, 3, 4, 6, 8 hours after intervention

Overall trial start date

17/09/2011

Overall trial end date

29/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy males or females
2. Aged 18 - 65

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Severe obesity, Body Mass Index (BMI) > 32 kg/m2
2. Metabolic and endocrine diseases
3. Malabsorption syndromes
4. Current smoking or smoking cessation for < 6 months
5. Alcohol abuse (> 40 g alcohol/d)
6. Pregnancy/lactation
7. Food allergy
8. Milk intolerance
9. Vegetarian
10. Blood donation or blood transfusion less than 3 months prior to the study
11. Major surgery within the 3 months preceding the study
12. Simultaneous participation in another drug trial and use of dietary supplements or any form of medication

Recruitment start date

17/09/2011

Recruitment end date

29/10/2011

Locations

Countries of recruitment

China

Trial participating centre

17 Tsing Hua East Road
Beijing
100083
China

Sponsor information

Organisation

China Agricultural University (China)

Sponsor details

College of Food Science and Nutritional Engineering
17 Tsing Hua East Road
HaiDian
Beijing
100083
China

Sponsor type

University/education

Website

http://www.cau.edu.cn/cie/en/

Funders

Funder type

Government

Funder name

National Science and Technology Support Program (China) ref: 2011BAD09B03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/06/2017: Plain English summary added.