MedTrace Logo

MOD Diet in Gestational Diabetes Mellitus

NCT04570111 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-09-10

No results posted yet for this study

Summary

Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet strategies that improve blood glucose in GDM and that patients can follow are needed for better clinical care. In studies of non-pregnant individuals with diabetes, eating a high fat/protein breakfast as the only dietary change was enough to improve glucose control. Because highest blood glucose readings in GDM usually occur after breakfast, a high fat/protein breakfast could also improve glucose control in GDM. In this study, two dietary strategies for improving blood glucose will be compared. Ten women newly diagnosed with GDM (\<30 weeks in pregnancy) will be enrolled in a 12-day cross-over controlled feeding study with a high fat/protein breakfast, which is named a 'Macro-Optimized Diet' (MOD) or standard care diet (SC). In other words, subjects will have all food provided to them, and they will consume each diet for a few days while researchers monitor their blood glucose. Most nutrition aspects of the two diets will be similar, but the MOD diet will vary the timing of eating carbohydrate, protein, and fat to achieve fewer carbs at breakfast. After the 12-day controlled feeding period, participants will continue one of the study diets (as randomized) until delivery. During this time, research team dietitians will provide personalized nutrition education to support GDM self-management. The study will evaluate whether the diet is acceptable to women with GDM and their clinic providers. Data to be collected include blood glucose data, patient and provider feedback on diet acceptability, weight gain, the number of participants who are prescribed blood glucose control medications, and infant weight. These data will be used to evaluate trends pointing to whether one diet is more effective.

Conditions

  • Gestational Diabetes

Interventions

OTHER

MOD Diet

The macro-optimized diet alters the timing of macronutrient intake to provide fewer carbohydrates at breakfast, while maintaining recommended amounts of macronutrients delivered throughout the course of the day

OTHER

Standard Care Diet

The standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Heather D Gibbs, PhD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570111 on ClinicalTrials.gov