NCT02288611

The Impact of Palm Date Intake on Colon Health Biomarkers

A Randomised, Controlled Intervention Trial to Assess the Impact of Palm Date Intake on Markers of Large Intestinal Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2014-11-11
• Last updated: 2014-11-11