Baby Bump Lifestyle Intervention Supplement Study

NCT03751813 | Terminated

• 1 other identifier: Baby BLISS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes

Outcome Measures

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.

  9 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo supplement

Dietary Supplement: Supplement

Supplement

EXPERIMENTAL

actual supplement

Dietary Supplement: Supplement

Interventions

Supplement DIETARY_SUPPLEMENT

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

Placebo; Supplement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman presenting to her first obstetrical visit for this pregnancy
• Must be in the first trimester (\<13 weeks)
• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

SUNY Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 23, 2018
• Study Start: March 21, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)