Colon CancerAJWANCT02288611
The Impact of Palm Date Intake on Colon Health Biomarkers
A study testing Date fruit - Ajwa variety and Maltodextrin/Dextrose in people with Colon Cancer, run by University of Reading.
Trial summary
This aim of this study is to investigate the prebiotic potential of date fruits in healthy human volunteers compared to a control diet. Each arm was 21 days in duration, separated by a 14 days washout period. Read more about this study
- Who is it for?
- Ages Up to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Date fruit - Ajwa variety and Maltodextrin/Dextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Signed consent form
- Body mass index - 18.5 - 30 inclusive
- Age 18 - 55 years
- Good general health as determined by medical questionnaires Requirements for diet and medication during study
- No intake of additional supplementary prebiotics (i.e. such as fructo-oligosaccharides) - please note that consumption of foods that are naturally prebiotic, e.g. cereal grains and leeks, may be consumed as normal
- No intake of probiotics (i.e. live yoghurts), drugs active on gastrointestinal motility, antibiotic treatment or any class of laxative
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- All concomitant medication must be recorded in diaries and case record forms
- Usual diet, fluid intake and exercise levels should be maintained during trial period
- Please inform the investigator if you consume antibiotics during the trial. You will not be able to continue, as this may affect your faecal bacteria.
Who cannot join
- Requirements to take long-term medication active on the gastro-intestinal tract
- Use of antibiotics within the previous 6 months
- Anaemia
- Diabetes mellitus
- History of alcohol or drug abuse
- Current smoker
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- Intake of any experimental drug within 4 weeks of the start of the study
- Excessive alcohol consumption (more than 21 units/wk male, 14 units/wk female)
- Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
- Major surgery, which might limit participation in, or completion of, the study.
- Participation in a study involving prebiotics or probiotics within the previous 3 months
- Physical or mental diseases that are likely to limit participation or completion of the study
- Severe allergy to foods or severe abnormal drug reactions
- Chronic gastroenterological complaints
- Intake of other supplementary prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class during or within the four weeks prior to the start of the study
- Aged below 18 or over 55 years
- Have a BMI of less than 18.5 or more than 30
- Gluten allergy
- Calorie restriction or other special diet (e.g. Atkins diet, montignac diet) 6 weeks prior to the start of the study
- Vaccination against with the current season's influenza and AH1N1 flu
- Manifestation of allergy, asthma and dermatitis
About this study
Official title: A Randomised, Controlled Intervention Trial to Assess the Impact of Palm Date Intake on Markers of Large Intestinal Health
This aim of this study is to investigate the prebiotic potential of date fruits in healthy human volunteers compared to a control diet. Each arm was 21 days in duration, separated by a 14 days washout period. Faecal samples, and blood samples will be collected from each volunteer and high resolution analytical techniques (HPLC, LC-MS and NMR) will be employed to characterise the whole system metabolic response to ingestion of date fruits compared to the control. Changes in microbial parameters and metabolite profiles will be correlated with changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular reactions, blood lipids and bowel movements.
Read the detailed description
This aim of this study is to investigate the prebiotic potential of date fruit consumption in healthy human volunteers compared to a diet which does not contain dates; control (maltodextrin-dextrose, 40.2g) or intervention treatment 7 date fruits (50g) to 22 healthy human volunteers. Each arm was 21 days in duration, separated by a 14 days washout period. Thus, we will also address fundamental questions about the relationship between fermentation of non digestible carbohydrates, the gut microbiota and the changes in faecal short chain fatty acids (SCFA profiles), ammonia and bile acids. To this end faecal samples, and blood samples will be collected from each volunteer and high resolution analytical techniques (High Performance Liquid Chromatography; Liquid Chromatography-Mass Spectrometry and Nuclear Magnetic Resonance) will be employed to characterise the whole system metabolic response to ingestion of date fruits compared to the control. Changes in microbial parameters and metabolite profiles will be correlated with changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular reactions, blood lipids and bowel movements.
- Conditions
- Colon Cancer
- Being tested
- Date fruit - Ajwa variety, Maltodextrin/Dextrose
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date fruit - Ajwa varietyDietary supplement
Also called Bateel Shop , London
Twenty-two healthy human individuals were randomly assigned to consume 7 date fruits (approx. 50g). Each arm was 21 days in duration, separated by a 14 days washout period.
Maltodextrin/DextroseDietary supplement
Twenty-two healthy human individuals were randomly assigned to consume Maltodextrin/dextrose , 40.2g. Each arm was 21 days in duration, separated by a 14 days washout period.
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin/Dextrose mix | Placebo comparator | Twenty-two healthy human individuals were randomly assigned to consume a control (maltodextrin-dextrose, 40.2g) at one of the arms period. Each arm was 21 days in duration, separated by a 14 days washout period.
P.S. placebo is called control in this study, where the bioactive comparator is a fruit. Receives: Dietary Supplement: Date fruit - Ajwa variety |
| Date fruit - Ajwa variety | Active comparator | Twenty-two healthy human individuals were randomly assigned to consume date fruits (approx. 50g) at one of the arms period. Each arm was 21 days in duration, separated by a 14 days washout period. Receives: Dietary Supplement: Maltodextrin/Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in large intestinal microbiota composition verses control intervention (0-3 months)
Microbial profile assessed by FISH
Measured: 3 months
Secondary outcomes (1)
Change from baseline in Bowel function verses the control intervention (0-3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- JEREMY PE SPENCER, PhD, Principal investigator, UNIVERSITY OF READING - FOOD AND NUTRITIONAL SCIENCES DEPARTMENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288611
- Sponsor's protocol ID
- AJWA STUDY
- Acronym
- AJWA
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eid NM, Al-Awadi B, Vauzour D, Oruna-Concha MJ, Spencer JP. Effect of cultivar type and ripening on the polyphenol content of date palm fruit. J Agric Food Chem. 2013 Mar 13;61(10):2453-60. doi: 10.1021/jf303951e. Epub 2013 Feb 26.
PubMed 23406291
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Intervention Trial to Assess the Impact of Palm Date Intake on Markers of Large Intestinal Health
- ClinicalTrials.gov ID
- NCT02288611
- Acronym / sponsor ID
- AJWA / AJWA STUDY
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This aim of this study is to investigate the prebiotic potential of date fruits in healthy human volunteers compared to a control diet. Each arm was 21 days in duration, separated by a 14 days washout period. Faecal samples, and blood samples will be collected from each volunteer and high resolution analytical techniques (HPLC, LC-MS and NMR) will be employed to characterise the whole system metabolic response to ingestion of date fruits compared to the control. Changes in microbial parameters and metabolite profiles will be correlated with changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular reactions, blood lipids and bowel movements.
Detailed description
This aim of this study is to investigate the prebiotic potential of date fruit consumption in healthy human volunteers compared to a diet which does not contain dates; control (maltodextrin-dextrose, 40.2g) or intervention treatment 7 date fruits (50g) to 22 healthy human volunteers. Each arm was 21 days in duration, separated by a 14 days washout period. Thus, we will also address fundamental questions about the relationship between fermentation of non digestible carbohydrates, the gut microbiota and the changes in faecal short chain fatty acids (SCFA profiles), ammonia and bile acids. To this end faecal samples, and blood samples will be collected from each volunteer and high resolution analytical techniques (High Performance Liquid Chromatography; Liquid Chromatography-Mass Spectrometry and Nuclear Magnetic Resonance) will be employed to characterise the whole system metabolic response to ingestion of date fruits compared to the control. Changes in microbial parameters and metabolite profiles will be correlated with changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular reactions, blood lipids and bowel movements.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin/Dextrose mix | Placebo comparator | Dietary Supplement: Date fruit - Ajwa varietyTwenty-two healthy human individuals were randomly assigned to consume a control (maltodextrin-dextrose, 40.2g) at one of the arms period. Each arm was 21 days in duration, separated by a 14 days washout period. P.S. placebo is called control in this study, where the bioactive comparator is a fruit. |
| Date fruit - Ajwa variety | Active comparator | Dietary Supplement: Maltodextrin/DextroseTwenty-two healthy human individuals were randomly assigned to consume date fruits (approx. 50g) at one of the arms period. Each arm was 21 days in duration, separated by a 14 days washout period. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Signed consent form
- Body mass index - 18.5 - 30 inclusive
- Age 18 - 55 years
- Good general health as determined by medical questionnaires Requirements for diet and medication during study
- No intake of additional supplementary prebiotics (i.e. such as fructo-oligosaccharides) - please note that consumption of foods that are naturally prebiotic, e.g. cereal grains and leeks, may be consumed as normal
Key exclusion criteria (21 listed)
- Requirements to take long-term medication active on the gastro-intestinal tract
- Use of antibiotics within the previous 6 months
- Anaemia
- Diabetes mellitus
- History of alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date fruit - Ajwa varietyAlso: Bateel Shop , LondonTwenty-two healthy human individuals were randomly assigned to consume 7 date fruits (approx. 50g). Each arm was 21 days in duration, separated by a 14 days washout period. | Dietary supplement | Maltodextrin/Dextrose mix |
| Maltodextrin/DextroseTwenty-two healthy human individuals were randomly assigned to consume Maltodextrin/dextrose , 40.2g. Each arm was 21 days in duration, separated by a 14 days washout period. | Dietary supplement | Date fruit - Ajwa variety |
Primary outcome
Change from baseline in large intestinal microbiota composition verses control intervention (0-3 months)
Time frame: 3 months
Microbial profile assessed by FISH
1 secondary outcome
Change from baseline in Bowel function verses the control intervention (0-3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Background: PubMed 23406291Eid NM, Al-Awadi B, Vauzour D, Oruna-Concha MJ, Spencer JP. Effect of cultivar type and ripening on the polyphenol content of date palm fruit. J Agric Food Chem. 2013 Mar 13;61(10):2453-60. doi: 10.1021/jf303951e. Epub 2013 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JEREMY PE SPENCER, PhD principal investigator
UNIVERSITY OF READING - FOOD AND NUTRITIONAL SCIENCES DEPARTMENT
Questions about this trial
What is this clinical trial studying?
A study testing Date fruit - Ajwa variety and Maltodextrin/Dextrose in people with Colon Cancer, run by University of Reading.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in large intestinal microbiota composition verses control intervention (0-3 months) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02288611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.