The Chocolate, Orange juice and Blackberry (COB) study
| ISRCTN | ISRCTN14271372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14271372 |
| ClinicalTrials.gov number | NCT01922869 |
| Secondary identifying numbers | 14638 |
- Submission date
- 22/07/2013
- Registration date
- 22/07/2013
- Last edited
- 25/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The era of general dietary recommendations for the whole population may be coming to an end, as it is becoming apparent that people do not respond in the same way to the same foods. Within a decade it is believed that individuals at risk of specific conditions will be easily identified and accordingly may be recommended personalised nutrition based on their genetic make-up. Food compounds known as flavonoids can be found in plant-based foods including fruits, tea and chocolate. The aim of this study is to determine whether the processing of flavonoids in the human body differs between individuals depending on age, gender, genetic make-up or the bacteria present in the gut.
Who can participate?
European Caucasian men and women (non-smokers) who are aged either 18-30 or 65-77 years and are generally healthy
What does the study involve?
Volunteers involved in the study first follow a dietary restriction by avoiding fruits, vegetables, wholegrain foods, tea, coffee or fruit juice for 3 days before the main study day (Day 4). On Day 4 they are asked to have a test meal consisting of a bar of chocolate and a glass of juice made from freeze dried blackberries and an extract of orange, which are rich in flavonoids. They are then be asked to provide a blood sample on Days 4 and 5 and provide urine samples on Days 3, 4 and 5. They are also asked to provide a faecal sample on either Day 3 or the morning of Day 4 before eating the test meal. All foods are provided on Days 4 and 5. The volunteers need to visit the clinical research facility a total of five times for the entire study (including a consent visit and a screening visit). Most of the visits take less than 1 hour each except for Day 4 (main study visit) which is about 8 hours long. Travel expenses are reimbursed and the volunteers receive £25 for their time.
What are the possible benefits and risks of participating?
This is a nutritional study and as such there will be no direct benefit to the participants in taking part in this study. However, the volunteers may benefit from knowing their blood chemistry and blood pressure results as part of the screening process for this study. There are no expected adverse effects of the intervention in this study, as the naturally occurring compounds are presented in food sources readily consumed in the habitual diet and at doses which can be readily achieved through normal dietary practices. As a safeguard, participants will be asked at screening whether they have known allergy to the study foods (chocolate, orange juice, blackberries).
Where is the study run from?
Clinical Research Facility at the Medical School of the University of East Anglia, Norwich (UK)
When is the study starting and how long is it expected to run for?
July 2013 to September 2014
Who is funding the study?
Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Who is the main contact?
Prof. Anne Marie Minihane
A.Minihane@uea.ac.uk
Contact information
Scientific
Department of Nutrition
Norwich Research Park
Medical School
Norwich
NR4 7 TJ
United Kingdom
| A.Minihane@uea.ac.uk |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Participants information can be found at http://www.cobstudy.org/what-is-the-study-about |
| Scientific title | A human acute flavonoid intervention study to examine flavonoid metabolism and the effect on memory/cognition |
| Study acronym | COB |
| Study objectives | Investigation of the genetic and phenotypic determinants of flavonoid absorption and metabolism. Assessing the influence of age, sex, gut microbiota and host genetics on inter-personal differences in flavonoid metabolism. |
| Ethics approval(s) | East of England, Norfolk, Research Ethics Committee, ref: 13/EE/0066 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Mixed flavonoid source, food source of a mixture of flavonoids. The study will be an acute nutritional intervention study. Volunteers will be asked to consume one dose of a flavonoid rich test meal, consisting of chocolate and a juice made from freeze dried blackberry powder and an extract of orange, providing approximately 640 mg of flavan-3-ols, 390 mg of anthocyanins and 342 mg of flavanones. The study takes 5 days in total, including 3 days of dietary restriction and 2 days of follow-up after the flavonoid rich test meal administration. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure for the study will be the measurement of the concentrations of flavonoids and their metabolites in blood and urine. They will be assessed in samples provided before the administration of the flavonoid rich test meal (24 hour pre-administration urine and a blood sample immediately before test meal administration) and several times after the test meal administration (7 regular blood samples over a 24 hour period and 2 x 24 hour urine, to be collected up to 48 hours after the test meal administration). Flavonoids and their metabolites will be assessed using state-of-the-art liquid chromatography-tandem mass spectrometry (LC-MS/MS) and quantified against commercially available standards. Serum and urine will be acidified and then extracted by solid phase extraction (SPE). Metabolite identification will be performed using a QTrap 4000 linear ion trap mass spectrometer (ABSciex, Canada) by multi-reaction monitoring (MRM) optimized for the detection of pure standards. Metabolites will be confirmed on the basis of retention time and parent-daughter ion fragmentation transitions. |
| Secondary outcome measures | The secondary outcome measure for the study will be to investigate the influence of gut microbiota variation on flavonoid absorption and metabolism. To do this, we will collect faecal samples and determine gut-microflora using faecal bacterial phylogenetic analysis using PCR to amplify 16S rDNA genes. Faecal samples will be collected within 24 hours before the administration of the flavonoid rich test meal. |
| Overall study start date | 08/07/2013 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 77 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240; Description: 18-30yrs (n=120) and 65-77yrs (n=120). Generally healthy, caucasian and non-smoker. |
| Key inclusion criteria | 1. Men and women 2. 18-30 years or 65-77 years 3. White Caucasian, of European origin 4. Non-smokers 5. Gnerally healthy |
| Key exclusion criteria | 1. Smoke 2. Are pregnant, have been pregnant in the last year or are breastfeeding 3. Have any existing medical conditions or significant past medical history likely to affect study measurements e.g., type 2 diabetes, cardiovascular, renal, liver, gastrointestinal diseases 4. Are on medication that may affect the study outcome 5. Have used antibiotics within the last three months 6. Have had vaccinations within the last three months 7. Take certain dietary supplements or herbal remedies and are unwilling to stop taking them 8. Have been involved in another research project within the last 3 months 9. Are unable to provide written informed consent 10. Have donated blood in the 16 weeks prior to the start of this study or intend to donate blood in the 16 weeks following this study 11. Have body mass index (BMI, kg/m2) <18.5 12. Have body mass index (BMI, kg/m2) >30 13. Have blood pressure < 90/60 mmHg 14. Have blood pressure > 140/90 mmHg |
| Date of first enrolment | 08/07/2013 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
NR4 7 TJ
United Kingdom
Sponsor information
University/education
Research and Enterprise Services
Norwich
NR4 7 TJ
United Kingdom
| Deborah.Graver@uea.ac.uk | |
| Website | http://www.uea.ac.uk/ |
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | oral presentation | 01/06/2014 | 25/04/2019 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/04/2019: Publication reference added.
13/03/2017: No publications found, verifying study status with principal investigator.
