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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39474161

Enrollment

160

Registered

2009-07-30

Start date

2009-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Micronutrient deficiencies, functional health Nutritional, Metabolic, Endocrine Other nutritional deficiencies

Interventions

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 leaf

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026