Baby Bump Lifestyle Intervention Supplement Study (Baby BLISS)

University at Buffalo (UB)

Status: Terminated

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03751813

Baby BLISS

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo supplement

Treatment:

Dietary Supplement: Supplement

Supplement

Experimental group

Description:

actual supplement

Treatment:

Dietary Supplement: Supplement