Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04051359
Description:
All women will be instructed to keep a diet of 25 kcal/kg/day for overweight and obese (pre-pregnancy BMI \>25) and 35 kcal/kg for women with normal weight (pre-pregnancy BMI 18.5-24.9).
The intervention (low carbohydrate intake = RCD) group will be instructed to keep a diet divided into 3 full meals and four snacks of 130 g/d (or at least 20% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-55% fat, and 20-25% protein). Protein content will be the same amount in both groups.
The standard carbohydrate diet (control group) group will be instructed to keep a diet divided into 3 full meals and four snacks of 200 g/d (or at least 40% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-45% fat, and 20-25% protein).
Study:
NCT04051359
Study Brief:
Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus