Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
21/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ruth Lambley- Burke

ORCID ID

Contact details

Lyndon
West Bromwich
B71 4HJ
United Kingdom

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 measures

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

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

http://www.swbh.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22136261

Publication citations

  1. 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.

Additional files

Editorial Notes