Glycemic Load, Metabolism & Obesity in Pregnancy

NCT01287299 | Completed

• 2 other identifiers: 2500-080R01HD046741
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Insulin Resistance

Keywords

pregnancy; obesity; diet glycemic load; body composition; body fat; gestational weight gain; insulin resistance

Outcome Measures

Primary Outcomes (1)

• maternal body fat gain

  Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation

  20-34 weeks gestation

Secondary Outcomes (1)

• Insulin Resistance

  20-34 weeks gestation

Study Arms (2)

Low Glycemic Load Diet

EXPERIMENTAL

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

Low Fat Diet

EXPERIMENTAL

Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.

Other: Low Fat Diet

Interventions

Low Glycemic Load diet OTHER

Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.

Also known as: LGL Diet

Low Glycemic Load Diet

Low Fat Diet OTHER

Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.

Also known as: LF Diet

Low Fat Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \>35% body fat
• to 40 years of age
• speak English or Spanish

You may not qualify if:

• have diabetes prior to pregnancy
• diagnosed with GDM in current pregnancy
• smoke
• abuse alcohol or drugs
• have a metabolic disease

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Gestational Weight Gain

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Weight Gain; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Janet C King, Ph.D.

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2011
• First Posted: February 1, 2011
• Study Start: July 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

US (1)