Skip to main content
OpenTrials
Completed

NCT Number: NCT01262781

Is Fructose Linked to Adiposity in Babies?

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. % 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.

    After delivery, neonatal adiposity will be measured using DEXA.

Secondary outcomes

  1. cord blood insulin (corrected by cord blood glucose)

    Time frame: At delivery (in the OR): 4-5 months after recruitment

  2. cord blood triglycerides

    Time frame: At delivery (in the OR): 4-5 months after recruitment

  3. cord blood leptin

    Time frame: At delivery (in the OR): 4-5 months after recruitment

  4. anthropometric measurements on the newborn

    Time frame: After delivery (4-5 months after recruitement)

    birth weight, arm, thigh, and abdominal circumference, subscapular skinfolds

  5. fetal fractional thigh volume obtained by fetal ultrasound

    Time frame: At 32 weeks gestation (4 months after recruitment)

    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.

  6. cord blood uric acid

    Time frame: At delivery (in the OR): 4-5 months after recruitment

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco General Hospital

Registry information

Acronym: FLAB

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 17, 2010
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.