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Is Fructose Linked to Adiposity in Babies? (FLAB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
San Francisco General Hospital
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01262781
First received: December 15, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

The obesity epidemic has reached down into the infant and toddler age group. Dietary indiscretion during pregnancy, particularly in our current food environment, is a major risk factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is itself a risk factor for obesity and metabolic syndrome in the offspring, possibly even during childhood. Temporal increases in fructose consumption in the last two decades coincide with temporal increases weight gain during pregnancy and with increased birth weight, including a higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.


Condition
Obesity
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Fructose Linked to Adiposity in Babies?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • % adiposity (DEXA) [ Time Frame: After delivery, neonatal adiposity will be measured using DEXA. This part of the protocol takes place 4-5 months after recruitment. ] [ Designated as safety issue: No ]
    After delivery, neonatal adiposity will be measured using DEXA.


Secondary Outcome Measures:
  • cord blood insulin (corrected by cord blood glucose) [ Time Frame: At delivery (in the OR): 4-5 months after recruitment ] [ Designated as safety issue: No ]
  • cord blood triglycerides [ Time Frame: At delivery (in the OR): 4-5 months after recruitment ] [ Designated as safety issue: No ]
  • cord blood leptin [ Time Frame: At delivery (in the OR): 4-5 months after recruitment ] [ Designated as safety issue: No ]
  • anthropometric measurements on the newborn [ Time Frame: After delivery (4-5 months after recruitement) ] [ Designated as safety issue: No ]
    birth weight, arm, thigh, and abdominal circumference, subscapular skinfolds

  • fetal fractional thigh volume obtained by fetal ultrasound [ Time Frame: At 32 weeks gestation (4 months after recruitment) ] [ Designated as safety issue: No ]
    The fetal fractional thigh volume will me measured in addition to routine fetal measurements at 32 weeks estimated gestation age. This measurement is a measure of neonatal adiposity.

  • cord blood uric acid [ Time Frame: At delivery (in the OR): 4-5 months after recruitment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The "fetal origins hypothesis" suggests that an individual's risk for obesity and metabolic disorders begins in utero; that fetal or early postnatal exposure to environmental factors, such as maternal nutrition or endocrine disrupting chemicals, adversely influences early development and results in permanent changes affecting energy storage and expenditure.

Most studies on "fetal origins" of obesity in the offspring have focused on maternal high-fat diets; yet dietary fat consumption has not changed appreciably in the last two decades. One chemical exposure in both pregnant mothers and newborns that has been steadily increasing worldwide is fructose. Although ostensibly a carbohydrate, fructose is a potent lipogenic substrate, and in the hypercaloric state, as much as 30% of an ingested fructose load undergoes de novo lipogenesis to form triglyceride thus the effects of high-fat and high-fructose diets in terms of physiology and outcome are comparable. Substituting sucrose (fructose + glucose) for glucose alone increases visceral adiposity, insulin resistance, and dyslipidemia in adult animals and humans. For humans, fructose is ubiquitous in the food environment, especially for pregnant mothers, who are often counseled to drink juice during pregnancy, as it is deemed to be healthier than soda. The effects of fructose consumption during pregnancy on infant birth weight and adiposity has not yet been studied.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women between 18 to 40 years of age are eligible for this study

Criteria

Inclusion Criteria:

  • Agreement to participate in all measurements
  • Plans to remain in the area through delivery
  • Ability to understand and give informed consent in either English or Spanish.

Exclusion Criteria:

  • Presence of diabetes prior to the index pregnancy
  • Presence of gestational diabetes during a previous pregnancy
  • Presence of diabetes or of other chronic metabolic disease such as cardiovascular disease, active thyroid disease, liver disease, pulmonary or psychiatric disorders, HIV
  • Any disorder requiring diet therapy (i.e., renal insufficiency)
  • Multiple gestation
  • Prior history of intrauterine growth retardation
  • Use of substances known to cause intrauterine growth retardation (e.g., smoking or drug use). -
  • Once recruited, any ultrasonographic evidence of intrauterine growth retardation during the course of the pregnancy would also lead to exclusion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262781

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
San Francisco General Hospital
Investigators
Principal Investigator: Robert Lustig, MD University of California, San Francisco
Study Director: Anjali Jain, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01262781     History of Changes
Other Study ID Numbers: SFGH 6281
Study First Received: December 15, 2010
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
neonatal adiposity
metabolic syndrome
fructose
maternal diet

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013