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Dietary Supplement

Very-Low Energy Diet for Preconception Health

N/A
Recruiting
Led By Amy Rothberg, MD, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery to 12 month follow-up
Awards & highlights

Study Summary

This trial will test whether weight loss before pregnancy can improve the health of both the mother and the fetus.

Who is the study for?
This trial is for obese women with a BMI between 30 and 45 who want to lose weight before getting pregnant. They should not have infertility issues, significant medical conditions, or a history of certain treatments like bariatric surgery. Healthy-weight women with a BMI up to 25 can also join.Check my eligibility
What is being tested?
The study tests if losing weight through a Very-low energy Diet (VLED) before conception leads to better health for the mother and baby compared to standard care. It aims to see if this improves birth outcomes and reduces future obesity risks in children.See study design
What are the potential side effects?
Potential side effects from VLED may include fatigue, nutrient deficiencies, hormonal changes affecting menstrual cycle or mood swings. Standard care typically has minimal side effects but does not offer the aggressive weight loss benefits of VLED.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery to 12 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery to 12 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cord blood related to neonate outcomes
DNA methylation
Metabolome and inflammatory markers
+2 more
Secondary outcome measures
Fetal growth will be assessed by ultrasound
Infant length and weight
Metabolite levels
+1 more
Other outcome measures
Fetal growth abnormalities
Maternal diagnosis
Mode of delivery

Trial Design

3Treatment groups
Experimental Treatment
Group I: Obese - Very low energy diet (VLED)Experimental Treatment1 Intervention
Participants will adopt a very-low energy diet
Group II: Obese - Standard of care (SOC)Experimental Treatment1 Intervention
Participants will receive the standard of care for obese women looking to become pregnant.
Group III: Lean - Standard of care (SOC)Experimental Treatment1 Intervention
Participants will receive the standard of care for lean women looking to become pregnant.

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Who is running the clinical trial?

University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,604 Total Patients Enrolled
34 Trials studying Obesity
9,965 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,889 Total Patients Enrolled
447 Trials studying Obesity
588,938 Patients Enrolled for Obesity
Amy Rothberg, MD, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Obesity
8 Patients Enrolled for Obesity

Media Library

Very-low energy Diet (VLED) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03244722 — N/A
Obesity Research Study Groups: Obese - Standard of care (SOC), Obese - Very low energy diet (VLED), Lean - Standard of care (SOC)
Obesity Clinical Trial 2023: Very-low energy Diet (VLED) Highlights & Side Effects. Trial Name: NCT03244722 — N/A
Very-low energy Diet (VLED) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03244722 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the patient count for this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this trial, which was first published on April 10th 2018, is currently recruiting for 352 participants from 1 medical centre."

Answered by AI

What are the major goals of this research initiative?

"The primary aim of this 16-week dietary intervention clinical trial is to quantify changes in offspring body fat mass. Secondary measures include infant length and weight, measured by trained staff using an infant length board and digital scale; metabolite levels between maternal blood at each trimester versus cord DNA methylation; as well as ultrasound assessment of gestational sac dimensions, fundal height, biparietal diameter, head circumference and waist circumference for fetal growth monitoring."

Answered by AI

Are there any eligibility criteria for me to join this scientific experiment?

"The criteria for admission into this clinical trial is weight loss and being between the ages of 18 and 40. This research project plans to enroll 352 total participants."

Answered by AI

Is the age limit for participating in this experiment over two decades old?

"Based on the standards stipulated by this investigation, individuals must be between 18 and 40 years old in order to join."

Answered by AI

Are there still openings available for participation in this experiment?

"As confirmed on clinicaltrials.gov, this research endeavour is currently seeking volunteers. The trial was published on April 10th 2018 and the latest update occurred on September 20th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've been overweight since childhood. I've tried over the counter fat Burning drugs, exercised, and dieted for YEARS. I'm ready to manage my weight before pregnancy, especially since a medication I've been on side effects made me gain over 100+ pounds.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes
Amy E Rothberg 2018. "Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03244722.
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