Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/06/2009
Date assigned
30/07/2009
Last edited
13/10/2014
Prospective/Retrospective
Prospectively 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

Prof Caroline Fall

ORCID ID

Contact details

Medical Research Council - Epidemiology Resource Centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial investigating the change in micronutrient status of Indian women as a result of consuming a micronutrient rich food

Acronym

Study hypothesis

Daily consumption of a fruit based supplement over a three-month period will produce an improvement in the nutrient status and in functional health indicators measured in young Indian women.

Ethics approval

Institutional Ethics Committee, Deaprtment of Pharmacology, Grant Medical College & Sir JJ Group of Hospitals, Mumbai, India, 07/10/2009, ref: No.IEC/Pharm/482/09

Study design

Interventional single-centre randomised non-blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Micronutrient deficiencies, functional health

Intervention

The intervention is an experimental food consumed six days per week. The experimental food is a micronutrient rich snack weighing approx 65 g, (energy value: about 180 kcal) containing 20 g green leafy vegetables (e.g. spinach, coriander, amaranth), 10 g fruit (figs, dates, raisins) and 12 g dried milk powder. The control food contains foods of low micronutrient content including potato, tapioca and onion. All snacks contain spices and binding ingredients such as flour and resemble a samosa or patty. There are a variety of recipes in the intervention and control groups to prevent monotony.

Total duration of treatment: 12 weeks; at present no follow-up is planned. Final measurements will be taken at 12 weeks after the start of supplementation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Serum retinol using high-performance liquid chromatography (HPLC)
2. Plasma vitamin C using HPLC
3. Serum folate and serum vitamin B12 using microbiological assays
4. Serum ferritin using enzyme-linked immunosorbent assay (ELISA) method

Samples taken at 0, 6 and 12 weeks after supplementation starts.

Added 13/10/2014:
5. Plasma and erythrocyte fatty acids, analysed using gas chromatography
6. Erythrocyte antioxidant enzyme SOD, analysed using enzyme-linked immunosorbent assay (ELISA) Cayman's kit
7. Erythrocyte antioxidant enzyme GPx, analysed using colorimeter
8. Plasma malondialdehyde, analysed spectrophometrically

These outcomes were measured at baseline (0 week) and 12 weeks after supplementation started.

Secondary outcome measures

1. Grip strength measured using a hand held dynamometer
2. Body composition by anthropometry
3. Changes in diet as a result of consumption of the snack measured using 3 x 24 hour recalls and a Food Frequency Questionnaire
4. Night blindness measured by questionnaire

Measurements made at 0 and 12 weeks after supplementation starts.

Overall trial start date

01/10/2009

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Aged 16 - 35 years
3. Living in the Ghatkopar area of Mumbai, India
4. Not pregnant
5. Not lactating
6. Willing to consume the snack food for 3 months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

160

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2009

Recruitment end date

01/01/2010

Locations

Countries of recruitment

India

Trial participating centre

Medical Research Council - Epidemiology Resource Centre
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK) - Epidemiology Resource Centre

Sponsor details

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Research council

Website

http://www.mrc.soton.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - Epidemiology Resource Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Centre for the Study of Social Change (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes