The effect of a micronutrient rich food on Indian women's health and nutrient status
| ISRCTN | ISRCTN39474161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39474161 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Medical Research Council - Epidemiology Resource Centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Interventional single-centre randomised non-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2009 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- India
- United Kingdom
Study participating centre
Medical Research Council - Epidemiology Resource Centre
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK) - Epidemiology Resource Centre
Research council
Research council
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Website | http://www.mrc.soton.ac.uk |
|---|---|
"ROR" |
https://ror.org/052578691 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) - Epidemiology Resource Centre
No information available
Centre for the Study of Social Change (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
