The effect of Oral High Energy Nutritional Supplements on appetite, pregnancy and fetal outcomes in underweight women during their first pregnancy

• Register: ISRCTN
• Last refreshed on: 12 December 2023
• Main ID: ISRCTN10088578
• Date of registration: 27/03/2018
• Prospective Registration: Yes
• Primary sponsor: Khyber medical university
• Public title: The effect of Oral High Energy Nutritional Supplements on appetite, pregnancy and fetal outcomes in underweight women during their first pregnancy
• Scientific title: Effect of high energy nutritional supplements on appetite regulators, energy intake and lipid profile in underweight primigravida
• Date of first enrolment: 01/04/2018
• Target sample size: 24
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10088578
• Study type: Interventional
• Study design: Single-blinded randomized placebo-controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Pakistan

Contacts

• Name: Kalsoom Tariq

• Name: Sadia Fatima

Key inclusion & exclusion criteria

Inclusion criteria:
1. Healthy
2. First pregnancy
3. Body mass index <18.5 kg/m2
4. Aged 15-45 years

Exclusion criteria:
1. Major illness such as gestational diabetes mellitus, pregnancy-induced hypertension, thyroid disease or liver disease
2. Previously on any long-term medication.
3. Allergic to supplement ingredients.
4. Previous history of gastrointestinal tract anomalies, surgeries and any other eating disorders e.g. bulimia nervosa, anorexia nervosa and purging disorders


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Low weight in women who are pregnant for the first time
Pregnancy and Childbirth
Malnutrition in pregnancy

Intervention(s)

After participants are recruited, written informed consent and a detailed medical history will be taken to exclude chronic illness, eating disorders, and major gastrointestinal operations. Each participant will be asked to participate in three main experimental trials conducted at baseline, 16th week of gestation and post-natally. In addition to antenatal treatment & supplements/placebo the participants will also be provided with nutritional counseling. At the beginning of the trial, the participants will be randomly allocated to receive either a high energy nutritional supplement or placebo by computerized randomization using free software (Research Randomiser version 3). On the baseline experimental day, the participant will be requested to visit the clinical trial room at Khyber Medical University, Peshawar. Participants will be provided with 10 minutes to rest and acclimatize with the environment and then anthropometric measurements will be taken. Afterwards baseline blood samples will be collected and an appetite questionnaire will be marked. Blood samples and data on appetite will be obtained in the fasted state, 30 min after supplementation and at 60, 120, 210 and 270 min. Participants will be provided with ad libitum buffet breakfast and ad libitum lunch. A complete record of antenatal visits and routine antenatal investigations including maternal mortality, maternal anemia (Hb<10 g/dl), miscarriage (loss of pregnancy before 28 weeks of gestation), placental abruption, pre-eclampsia, mode of delivery and congenital anomalies will be maintained by the researcher. Participants will be asked to consume the supplements/placebo in addition to their habitual diet and antenatal treatments including supplements prescribed by their doctor throughout the pregnancy and on

Primary Outcome(s)

1. Energy consumed during the days prior to experimental trial and during ad libitum breakfast and lunch calculated using dietary analysis software (Windiets 2005, The Robert Gordon University, Aberdeen, Scotland, UK)
2. Appetite measured using a validated appetite questionnaire at baseline, week 16 and postnatally
3. Lipid profile analyzed using Cobas C3 analyzer
4. Maternal hemoglobin, hematocrit and mean corpuscular volume measured by hematology analyzer at baseline, week 16 & potnatal visit
5. Pregnancy outcome
6. Iron, zinc and calcium levels in cord blood analyzed by atomic absorption spectrometry (AAS)
7. Iron, zinc and calcium levels in colostrum measured by Cobas 8000 Modular Analyzer

Secondary Outcome(s)

1. Maternal satisfaction and compliance
2. Socioeconomic data

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Khyber medical university

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Not provided at time of registration. An application has been made to the ethical approval committee of Khyber Medical University.

Results

• Results available: Yes
• Date Completed: 01/11/2023