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Dietary Supplement

Very-Low Energy Diet for Preconception Health

N/A
Waitlist Available
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
Must not have
Endometriosis AFS (American Fertility Society classification class III or IV)
Previous bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery to 12 month follow-up
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My endometriosis is classified as severe.
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I have had weight loss surgery in the past.
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I have serious health issues like heart, kidney, liver, or autoimmune diseases.
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I have severe anemia.
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My cancer is not a minor skin cancer.
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I have recently used drugs for weight loss or to suppress my appetite.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,432,673 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,480 Total Patients Enrolled
Amy Rothberg, MD, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Very-low energy Diet (VLED) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03244722 — N/A
Pregnancy Research Study Groups: Obese - Standard of care (SOC), Obese - Very low energy diet (VLED), Lean - Standard of care (SOC)
Pregnancy 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
~17 spots leftby Apr 2025
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