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
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