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TerminatedNCT03751813Baby BLISSUpdated Feb 20, 2020

Baby Bump Lifestyle Intervention Supplement Study

An interventional study of Supplement in Gestational Diabetes, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment

Why this study was terminated
IRB had concerns about study; terminated
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.

02

Conditions studied

  • Gestational Diabetes

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03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 4 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant woman presenting to her first obstetrical visit for this pregnancy
  • Must be in the first trimester (\<13 weeks)
  • 18 years or older
  • High-stress levels as measured by the Perceived Stress Level Questionnaire
  • Must be a single pregnancy (e.g. not twins, triplets, etc.)

Exclusion criteria

Exclusion Criteria:

  • Diabetes (types 1 and 2)
  • Diagnosis of gestational diabetes in prior pregnancy
  • Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake
  • Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    placebo supplement

    Dietary Supplement: Supplement

  • Experimental
    Supplement

    actual supplement

    Dietary Supplement: Supplement

Interventions

  • Dietary supplementSupplement

    Supplement will be given to this group to take daily for 8 weeks

06

What researchers measure

Primary outcomes

  1. lower blood stress markers via venous draw

    We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.

    Time frame: 9 months

07

Study locations

1 site
  • SUNY Buffalo
    Buffalo, New York 14214, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03751813
Lead sponsor
State University of New York at Buffalo
Responsible party
Kai Ling Kong (Principal Investigator, State University of New York at Buffalo) — Principal investigator
First posted
Nov 23, 2018
Start date
Mar 21, 2019
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Last update
Feb 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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