Status:
COMPLETED
The Impact of Palm Date Intake on Colon Health Biomarkers
Lead Sponsor:
University of Reading
Conditions:
Colon Cancer
Eligibility:
All Genders
Up to 55 years
Phase:
NA
Brief 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...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02288611
Start Date
May 1 2012
End Date
September 1 2014
Last Update
November 11 2014
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