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. 2021 Jun 21;17(2):e1150. doi: 10.1002/cl2.1150
Methods Study design: Randomized controlled trial
Unit of randomization: Individually randomised
Type of study: Balanced Energy Protein
Participants Location/setting: Metabolic ward of St. John's Research Institute, Bangalore, India
Population: Not specified
Sample size: 24
Drop outs/withdrawal: None
Socio‐demographics
Mean (SD) age: Total: 22.9 (3.24), Intervention: 23.7 (4.1), Control: 22.2 (1.99)
Occupation: Not specified
Race: Not specified
Education: Not specified
Family income: Not specified
Inclusion criteria:
Only pregnant women from the same dwelling area and similar socioeconomic background were invited to join the study. Pregnant women at <13 weeks of gestation with low BMIs (≤18.5) and normal plasma folate and vitamin B‐12 status were identified and invited
Exclusion criteria:
Women with multiple pregnancies, those with a clinical diagnosis of chronic illness (e.g., diabetes mellitus, hypertension, cardiac disease, thyroid disease, or epilepsy), and those who tested positive for hepatitis B surface antigen, HIV, or syphilis were excluded
Interventions Intervention (sample size):
In addition to their normal habitual diet, the supplemented group received a daily dietary supplement of 300 kcal/day energy and 15 g protein/day (i.e., 20% of energy from protein), provided as 3 small, round granola‐type treats, called “ladoos“ in the local language, and made of crushed roasted peanuts, puffed rice, skimmed milk, clarified butter, and unrefined sugar from 1st trimester till delivery. Intervention was delivered by a social worker (n = 12)
Control (sample size):
No supplementation. The control group continued to consume their habitual diet. It was delivered by a social worker
(n = 12)
Training: Not specified
Follow‐up:
Protein kinetics and serine and glycine fluxes were measured by using standard stable isotope tracer methods in the fasting and postprandial state at end of 1st and beginning of 3rd trimester. 24‐h food recalls were obtained three times during each trimester of pregnancy
Outcomes Primary outcomes: Miscarriage
Secondary outcomes:
Low birthweight
Preterm birth
Small‐for‐gestational age
Birth weight
Birth length
Timing of outcome assessment: At birth
Notes Study start date: Not specified
Study end date: Not specified
Time period: Not specified
Study country: India
Study limitations: The sample size was relatively small.
Funding source:
Supported by federal funds from the USDA, Agricultural Research Service, under Cooperative Agreement 58‐6250‐6001
Conflict of interest: None