An interventional study of Low Glycemic Load diet and Low Fat Diet in Obesity and Insulin Resistance, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Prevention
The purpose of the study is to determine if a low glycemic load diet reduces the gain of body fat and insulin resistance during the last half of pregnancy in obese women.
Obese women will be recruited to participate in the study between 14-18 weeks gestation. After determining usual dietary intakes, visceral fat thickness, and the metabolic response to a 100g oral glucose tolerance test (OGTT) at 20 weeks gestation, 45 of the women will be randomly assigned to a low glycemic load (GL) diet and 65 women to a regular low fat diet (current standard care). They will follow their assigned diet for the last 20 weeks of gestation. A dietitian will advise the women and will monitor them throughout the study. At 28 and 34 weeks gestation, the women will come to the General Clinical Research Center (GCRC) at San Francisco General Hospital in the fasting state and the hormonal and metabolic response will be measured to another 100g oral glucose tolerance test (OGTT), and total body fat will be measured. Additional measurements include: 1) longitudinal measurements of maternal visceral fat thickness and fetal size and adiposity at 20 and 34 weeks gestation by ultrasound, 2) collection of cord blood and placental tissue, and 3) measurement of neonatal body composition by dual-energy x-ray absorptiometry and anthropometry at 2-3 weeks of age. Birth outcome data for mother and infant will be collected. To determine the metabolic response to the study diet, 25 women from each of the two diet groups will be assigned to a metabolic subsample for measuring rates of hepatic glucose production and lipolysis at 34 weeks.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 64 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 53 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Counseled to consume a diet with a low or higher intake of carbohydrate sources that cause rapid or significant intakes in blood glucose. The average glycemic load of the diet should be less than 55 per 1000 calories or greater than 55 per 1000 calories.
Other: Low Glycemic Load diet
Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.
Other: Low Fat Diet
Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.
Also known as: LGL Diet
Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.
Also known as: LF Diet
maternal body fat gain
Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation
Time frame: 20-34 weeks gestation
Insulin Resistance
Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.
Time frame: 20-34 weeks gestation
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland