The Impact of Palm Date Intake on Colon Health Biomarkers

NCT02288611 | Completed

• 1 other identifier: AJWA STUDY
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in large intestinal microbiota composition verses control intervention (0-3 months)

  Microbial profile assessed by FISH

  3 months

Secondary Outcomes (1)

• Change from baseline in Bowel function verses the control intervention (0-3 months

  3 months

Study Arms (2)

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.

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.

Dietary Supplement: Maltodextrin/Dextrose

Interventions

Date fruit - Ajwa variety DIETARY_SUPPLEMENT

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.

Also known as: Bateel Shop , London

Maltodextrin/Dextrose mix

Maltodextrin/Dextrose DIETARY_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.

Date fruit - Ajwa variety

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Related Publications (1)

• 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.

  PMID: 23406291 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

maltodextrin; Glucose

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• JEREMY PE SPENCER, PhD

  UNIVERSITY OF READING - FOOD AND NUTRITIONAL SCIENCES DEPARTMENT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biochemistry

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 11, 2014
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11