| CTRI Number |
CTRI/2025/03/083670 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food Intervention (Mixed Nuts)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of mixed nuts on pregnant women and newborn. |
|
Scientific Title of Study
|
Impact of Mixed Nuts on the Nutritional Status of Pregnant Women and their Newborn: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Pareek |
| Designation |
Associate Professor and HOD Department of Clinical Nutrition |
| Affiliation |
MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Navi Mumbai |
| Address |
4th floor, Department of Clinical Nutrition, MGM School of Biomedical Sciences, MGM Medical College building, MGM Hospital Campus, Sector-1 Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8143640995 |
| Fax |
|
| Email |
priyankapareekcn1681@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Shravya Karkera |
| Designation |
PhD Student, Department of Clinical Nutrition |
| Affiliation |
MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Navi Mumbai |
| Address |
4th floor, Department of Clinical Nutrition, MGM School of Biomedical Sciences, MGM Medical College building, MGM Hospital Campus, Sector-1 Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9004767684 |
| Fax |
|
| Email |
karkerashravya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Pareek |
| Designation |
Associate Professor and HOD Department of Clinical Nutrition |
| Affiliation |
MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Navi Mumbai |
| Address |
4th floor, Department of Clinical Nutrition, MGM School of Biomedical Sciences, MGM Medical College building, MGM Hospital Campus, Sector-1 Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8143640995 |
| Fax |
|
| Email |
priyankapareekcn1681@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences, Sector-1 Kamothe,Navi Mumbai, Maharashtra, India - 410209. |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Pareek |
| Address |
4th floor, MGM School of Biomedical Sciences, MGM Medical College Building, MGM Institute of Health Sciences, MGM Hospital Campus, Sector -1 Kamothe, Navi Mumbai, Maharashta, India - 410209. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Sharma |
MGM Womens Hospital, Kalamboli |
Department of Obstetrics and Gynaecology, MGM Womens Hospital, Kalamboli, Navi Mumbai
Raigarh
MAHARASHTRA |
9930851570
sunilsharma2860@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Women in 1st Trimester and their newborn child (post delivery) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mixed Nuts |
30 gm Mixed Nuts (10 gm of Almonds, walnuts and cashews each) from 1st trimester till delivery. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida pregnancy (6 weeks to 12 weeks).
Willing to participate. |
|
| ExclusionCriteria |
| Details |
High risk pregnancies (underweight, overweight, severely anemic, HIV, GD, PIH, Above the age of 35yrs and multiple pregnancies).
Abortion or miscarriage prior to current pregnancy.
Assisted conception (Fertility Medication, Assisted Reproductive Technology, IVF, etc).
Suffering from chronic illnesses (heart problem, kidney disorder, liver disease, diabetes and cancer).
Those who are consuming nuts on daily basis at home.
-underweight and overweight will be based on pre pregnancy body weight. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nutritional status of pregnant women during different trimesters.
Impact of nuts consumption on nutritional status and Essential Fatty Acid profile of pregnant women.
Impact of nuts consumption on growth of foetus and newborn. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anxiety and depression levels of pregnant women during different trimesters.
Dietary pattern of pregnant women. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Randomized Controlled Trial aims to evaluate the impact of daily nut consumption on the nutritional status of pregnant women and the
health outcomes of their newborns, including effects on maternal micronutrient levels, overall dietary
intake, and newborn birth weight and growth parameters. This study will help us gain a better understanding of the effects of nuts consumption on pregnant women and
newborn babies. |