ObesityFLABNCT01262781
Is Fructose Linked to Adiposity in Babies?
An observational study of Obesity and Metabolic Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 18 to 40 years of age are eligible for this study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- neonatal adiposity, metabolic syndrome, fructose, maternal diet
- Medical subject headings
- Obesity, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
% adiposity (DEXA)
After delivery, neonatal adiposity will be measured using DEXA.
Measured: After delivery, neonatal adiposity will be measured using DEXA. This part of the protocol takes place 4-5 months after recruitment.
Secondary outcomes (6)
cord blood insulin (corrected by cord blood glucose)
Measured: At delivery (in the OR): 4-5 months after recruitment
cord blood triglycerides
Measured: At delivery (in the OR): 4-5 months after recruitment
cord blood leptin
Measured: At delivery (in the OR): 4-5 months after recruitment
anthropometric measurements on the newborn
birth weight, arm, thigh, and abdominal circumference, subscapular skinfolds
Measured: After delivery (4-5 months after recruitement)
fetal fractional thigh volume obtained by fetal ultrasound
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.
Measured: At 32 weeks gestation (4 months after recruitment)
cord blood uric acid
Measured: At delivery (in the OR): 4-5 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco General Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Lustig, MD, Principal investigator, University of California, San FranciscoAnjali Jain, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262781
- Sponsor's protocol ID
- SFGH 6281
- Acronym
- FLAB
- Status last verified
- Apr 2014
- First submitted
- 15 Dec 2010
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fructose Linked to Adiposity in Babies?
- ClinicalTrials.gov ID
- NCT01262781
- Acronym / sponsor ID
- FLAB / SFGH 6281
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- neonatal adiposity, metabolic syndrome, fructose, maternal diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco General Hospital
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 18 to 40 years of age are eligible for this study
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% 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.
6 secondary outcomes
cord blood insulin (corrected by cord blood glucose)
Time frame: At delivery (in the OR): 4-5 months after recruitment
cord blood triglycerides
Time frame: At delivery (in the OR): 4-5 months after recruitment
cord blood leptin
Time frame: At delivery (in the OR): 4-5 months after recruitment
anthropometric measurements on the newborn
Time frame: After delivery (4-5 months after recruitement)
fetal fractional thigh volume obtained by fetal ultrasound
Time frame: At 32 weeks gestation (4 months after recruitment)
cord blood uric acid
Time frame: At delivery (in the OR): 4-5 months after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Lustig, MD principal investigator
University of California, San Francisco
Anjali Jain, MD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.