Recruiting

High-Protein Beverages

Sponsor:

Medical College of Wisconsin

Code:

NCT07571343

Conditions

Diabetes During Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Protein Beverage (Genius Gourmet Sparkling Protein Water)

Standard Clear Liquid Diet

Continuous Glucose Monitoring (Abbott Freestyle Libre)

Study Details

Brief summary:

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with insulin-treated diabetes. It will also help us learn if this approach is acceptable and well-tolerated by patients. The main questions it aims to answer are:

  • Does drinking high-protein beverages during labor keep blood sugar in a healthier range compared to drinking standard clear liquids?
  • How do participants feel about drinking protein beverages during labor, and does it affect their energy levels and birth experience?
  • Is the baby less likely to have low blood sugar after birth when the mother drinks protein beverages during labor?

Researchers will compare women who drink high-protein beverages to women who drink standard clear liquids (like juice, broth, and popsicles) to see if protein drinks help keep blood sugar more stable during labor.

Participants will:

  • Wear a small, painless glucose sensor on their arm from when labor starts until about one week after giving birth
  • Be randomly assigned to either drink a clear protein beverage every 4 hours during labor OR drink standard clear liquids as usual
  • Complete short surveys about how tired they feel during labor, their overall birth experience, and their overall experience with the glucose sensor

Conditions

Diabetes During Pregnancy

Study ID

NCT07571343

Start date

Jul 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Singleton pregnancy
  • Gestational age ≥37 0/7 weeks at time of induction
  • Diagnosis of gestational diabetes requiring insulin therapy (GDM A2) or pre-existing Type 2 diabetes managed with insulin during pregnancy
  • Admission to labor and delivery for induction of labor
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Multifetal gestation
  • Major fetal anomalies or conditions affecting neonatal glucose regulation
  • Stillbirth
  • Planned cesarean delivery
  • Inability to provide consent
  • Contraindication to oral intake (e.g., NPO status for clinical indication)
  • Known allergy or intolerance to study materials, including components of the high-protein supplement or CGM device

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High-Protein Supplementation

Participants will be offered Genius Gourmet Sparkling Protein Water (approximately 30 g protein, 0 g carbohydrate, 0 g fat, 130 kcal per 12-ounce serving) every 4 hours beginning at randomization until delivery. Consumption is voluntary. All participants will wear a blinded CGM from admission through 7 days postpartum.

active comparator: Standard Clear Liquid Diet

Participants will receive standard institutional clear liquid diet (water, ice chips, clear fruit juices, clear carbonated beverages, popsicles, clear broth, gelatin) ad libitum throughout labor per routine institutional practice. All participants will wear a blinded CGM from admission through 7 days postpartum.

Interventions

High-Protein Beverage (Genius Gourmet Sparkling Protein Water)

Clear, carbonated, commercially available high-protein nutritional supplement containing approximately 30 g protein, 0 g carbohydrate, 0 g fat, and 130 kcal per 12-ounce serving. Offered every 4 hours during labor. Multiple flavors available (participant's choice).

Standard Clear Liquid Diet

Standard institutional clear liquid diet including water, ice chips, clear fruit juices (e.g., apple juice), clear carbonated beverages (e.g., ginger ale), popsicles, clear broth, and gelatin. Carbohydrate-containing clear liquids permitted per standard practice.

Continuous Glucose Monitoring (Abbott Freestyle Libre)

Abbott Freestyle Libre 2 or Libre 3 CGM sensor placed on upper arm upon admission. Sensor remains in place through delivery and up to 7 days postpartum. CGM data blinded to participants and clinical staff during labor.

Primary outcome measure

  • Percent Time Above Range (TAR >110 mg/dL) During Labor [ Time Frame: From admission to delivery (expected ≤72 hours) ]

Central Contacts and Locations

Central contacts

Sukanya Skandarajah

4148055337sskandarajah@mcw.edu

Brock Polnaszek, MD

4148056624bpolnaszek@mcw.edu

Locations

Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Intrapartum glucose control
  • continuous glucose monitoring
  • Protein supplementation
  • diabetes in pregnancy
  • time above range

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.