The Impact of Palm Date Intake on Colon Health Biomarkers
NCT ID: NCT02288611
Last Updated: 2014-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2012-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Maltodextrin/Dextrose mix
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.
Date fruit - Ajwa variety
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.
Date fruit - Ajwa variety
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.
Maltodextrin/Dextrose
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.
Interventions
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Date fruit - Ajwa variety
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/Dextrose
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* Use of antibiotics within the previous 6 months
* Anaemia
* Diabetes mellitus
* History of alcohol or drug abuse
* Current smoker
* 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
55 Years
ALL
Yes
Sponsors
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University of Reading
OTHER
Responsible Party
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Jeremy Paul Edward Spencer
Professor of Biochemistry
Principal Investigators
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JEREMY PE SPENCER, PhD
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY OF READING - FOOD AND NUTRITIONAL SCIENCES DEPARTMENT
References
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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.
Other Identifiers
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AJWA STUDY
Identifier Type: -
Identifier Source: org_study_id