Effect of antenatal use of high energy nutritional supplements on cardio metabolic risk markers in underweight primi gravidas; a randomized controlled trial | BMC Pregnancy and Childbirth

The Advanced Study and Research Board (ASRB) authorized (ASRB000669/EH/IBMS) and the Ethical Committee of Khyber Medical University approved this study under (DIR/KMU-EB/EH/000453) and permission was taken from the respective tertiary care hospitals. This trial is also registered in ISRCTN registry under (ISRCTN 10088578) dated 27/03/2018. Our study adheres to CONSORT guidelines. After obtaining the approval, recruitment was started from the province of Khyber Pakhtunkhwa tertiary care facilities and clinical trial room set up in those respective hospitals for the convenience of the participants. Simple random sampling was done and Open Epi software was used to calculate sample size. This sample size was calculated based on the difference in the main outcomes of this study (Insulin) from studies conducted by Stratton et al. 2008 and Fatima et al. 2015, considering 85% power and CI of 95%, 24 participants are required to conduct this study [18, 19]. Keeping in mind 20% dropout rate, Thirty six Primi underweight participants were selected from the OPDs of the concerned gynecology and obstetrics departments.

It was a single blinded randomized controlled trial in which participants are randomly assigned to either the intervention group (receiving the supplement) or the control group (receiving a placebo) using Computor randomizer(version3). Only the participants are unaware of which group they have been assigned to, while the researchers administering the treatment knew which participants are in the intervention or control groups.

Inclusion criteria

Underweight primigravidas having a BMI < 18.5 kg/m².

Exclusion criteria

underweight primigravida having any major illness like hypertension, gestational diabetes mellitus, thyroid or liver disorders. Also those primigravidas already on long term supplementation or other medication or having allergy to supplements were excluded from this study.

The recruitment of the participants is shown in Fig. 1. The participants were informed about the objectives of this study and informed consent was asked for at the start of the study.Participant were requested to make three visits, one at baseline, second between 16 and 20 weeks gestation and a post natal visit. Nutritional counseling was given to the participants in addition to prenatal care.

recruitment of participants for this study

A high-energy nutritional supplement called “MAAMTA” with 400 kcal/75 gm of energy that was made with peanut butter was given to the HENS group, while the placebo consisted of 75 gm of wheat flakes, 40 ml of skimmed milk, and two tablets of artificial sweetener (Canderal). Per 75 grammes, it contains 137.8 calories (Fig. 2). The participants were asked not to discard the sachet s of their supplements/placebo, which were collected by the main researcher at the end of each week. Any leftovers in the sachet were measured and deducted from 75gms to make sure the exact amount taken by the participants.In addition to their regular diet and prenatal care, participants of both groups were instructed to take the HENS/placebo throughout the duration of their pregnancy as well as one week after giving birth.

For baseline visit the participants were invited to attend a trial in the trial room in a fasted state. After they were acclimatized to the environment, anthropometric measurements were taken and 5 ml blood was taken from them in a 5 ml BD syringe, then the plunger was removed (to avoid hemolysis) and 2 ml of this blood was put into an EDTA vacutainer TM tube, 2 ml in gel tube and 1 ml in an Eppendorf tube containing 200 µl of aprotonin (a bovine origin pancreatic inhibitor).The sample with EDTA and aprotonin were put in the refrigerator while the sample in gel tube was placed in a stand for serum to get separated. Afterwards were served with juice and light breakfast. They were given incentive of Rs.1000 and were also given nutritional counseling. The date for their next visit was calculated and written on their prescription from their antenatal visit. They were reminded of the second visit two days before the visit telephonically. The same procedure was repeated as on the first visit. Similarly, they were asked to make a post natal visit, after their condition was stabilized. Fasting blood samples and anthropometric measurements were taken.

The anthropometric measurements that were taken included, height using a seca Leicester 214 (portable standiometer) and weight, body fat, hydration and bone was calculated using bioelectrical impedance scale by (Beurer GmbH, Soflinger str.218 89077 Ulm, Germany Art._Nr.748.13, TypeBF220). The mid upper arm circumference (MUAC) was determined using a strip used was a validated World Food Programme strip. The same strip was used throughout the study.

Metabolic Syndrome Criteria (NCEP ATP III, IDF, WHO) [20] was used to assess cardiometabolic risk factors. Metabolic syndrome is a significant indicator of cardiometabolic risk. The criteria vary slightly between different guidelines, but typically include:

• Waist circumference (Central Obesity)

• NCEP ATP III: ≥102 cm (40 inches) for men, ≥ 88 cm (35 inches) for women.

• IDF: ≥94 cm for men, ≥ 80 cm for women (values may differ by ethnicity).

Having three or more of these factors typically indicates metabolic syndrome.

Data analysis

Biochemical parameters like Insulin was analysed by the electro chemi luminescent immunoassay “ECLIA”technique. Fasting blood glucose and lipid profile by enzymatic colorimetric method using cobas501 analyzer.

Insulin resistance

The HOMA model by Matthews et al.,1985 has shown to be a valid clinical and epidemiological technique for assessing insulin resistance. HOMA uses a basic nonlinear equations to describe glucose insulin homeostasis [21].

HOMA_IR index is calculated according to the formula.

HOMAIR; fasting glucose in m mol/l × fasting insulin in mU/ml/22.5

Statistical analysis

Statistical analysis was performed using version 20 of IBM SPSS ^®. Weight, height, age, and BMI were taken as mean ± standard deviation. Normality of the data was checked using Shapiro-Wilk test while the primary & secondary outcomes was analysed using repeated measure ANOVA. Mauchly sphericity test was employed for P value reporting, in case of sphericity was not significant then we used Greenhouse-Geisser test. Insulin resistance was calculated by HOMA_R model.

Nutritional value of 75gms of MAAMTA and Placebo