Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6811
Study information
Scientific title
Acronym
DRN 335 DHRMA
Study hypothesis
The DHRMA study will focus on testing two distinct hypotheses using two separate studies:
1. Glycaemic index study:
1.1. The glycaemic index (GI) of DHRMA basmati rice (KETT less than 35%) is lower than UK traditional basmati rice or UK Super Basmati (KETT greater than 40%) and comparable to unrefined rice from rural Gujarat (jya and mysuri kernels); and
1.2. The GI of DHRMA stone-ground flour is lower than UK white and brown and wholemeal chapatti flour, but comparable to hand-milled flour from rural India
2. Interventional study:
We will test the hypothesis that intervention with a low GI, carbohydrate rich/low fat diet will result in favourable changes in metabolic, diabetes and CHD risk indices compared to a high GI, carbohydrate rich/low fat diet.
Ethics approval
MREC approved (ref: 08/H1204/130)
Study design
Single centre randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Other; Disease: Diabetic Control, Metabolic
Intervention
The use of stone ground flour or rice with a low glycaemic index as compared to the use of flour or rice with a higher glycaemic index.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To determine whether the rice and chappati flour test foods (DHRMA) exhibit a more favourable outcome
Secondary outcome measures
1. To develop foods for DHRMA that mimic those available in rural Gujarat
2. Diabetes and macrovascular risk
3. Glycaemic index (GI)
Overall trial start date
31/03/2009
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/03/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lyndon
West Bromwich
B71 4HJ
United Kingdom
Sponsor information
Organisation
Sandwell and West Birmingham Hospitals NHS Trust (UK)
Sponsor details
Lyndon
West Bromwich
B71 4HJ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22136261
Publication citations
-
Protocol
Patel JV, Hughes EA, Lip GY, Gill PS, Diabetes Health, Residence & Metabolism in Asians: the DHRMA study, research into foods from the Indian subcontinent - a blinded, randomised, placebo controlled trial., BMC Cardiovasc Disord, 2011, 11, 70, doi: 10.1186/1471-2261-11-70.