The effect of a micronutrient rich food on Indian women's health and nutrient status

ISRCTN	ISRCTN39474161
DOI	https://doi.org/10.1186/ISRCTN39474161
Protocol serial number	N/A
Sponsor	Medical Research Council (MRC) (UK) - Epidemiology Resource Centre
Funders	Medical Research Council (MRC) (UK) - Epidemiology Resource Centre, Centre for the Study of Social Change (India)

Submission date: 16/06/2009
Registration date: 30/07/2009
Last edited: 13/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Caroline Fall
Scientific

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

Study information

Primary study design	Interventional
Study design	Interventional single-centre randomised non-blinded controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial investigating the change in micronutrient status of Indian women as a result of consuming a micronutrient rich food
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	160
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/2009
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

United Kingdom
England
India

Study participating centre

Medical Research Council - Epidemiology Resource Centre

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes