Lactoferrin-enriched Dairy Product in Gestational Diabetes

Effects of a Dairy Product Enriched With Lactoferrin on Iron Status of Women With Gestational Diabetes. A Pilot Randomized Controlled Double-blind Trial

This pilot double-blind, randomized controlled trial with two parallel arms, was performed to evaluate the change in serum ferritin concentration following consumption of lactoferrin enriched yogurt versus the non-enriched control yogurt in women with GDM.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Dietary supplement: Lactoferrin-enriched yogurt supplementation; Dietary supplement: Non-enriched yogurt

Detailed Description

Lactoferrin is recognized as both effective and safe during pregnancy. Nonetheless, studies specifically investigating its effects in women with GDM are limited.

The primary outcome of this pilot RCT was the change in serum ferritin concentration following the consumption of lactoferrin-enriched yogurt compared with non-enriched control yogurt. Secondary outcomes included changes between the two arms in hemoglobin concentration, hematocrit, red blood cell count, serum iron, transferrin levels, total iron-binding capacity, and transferrin saturation. Additional outcomes were the evaluation of variations in metabolic variables, the occurrence of adverse maternal and neonatal outcomes, and changes in the maternal gut microbiota before and after the intervention

The study began on March 1, 2023, and continued until May 31, 2025. All participants with diagnosis of GDM were recruited according to the inclusion criteria.

Participants received the same dietary counseling and nutritional recommendations aligned with current guidelines by trained registered dieticians. Women were randomized to receive the lactoferrin-enriched yogurt (experimental arm, n=25) and the non-enriched control yogurt (control arm, n=25). Both products were derived from high-quality cow's milk, had the same color, flavor, texture, and were contained in identical unlabeled white 125g plastic cups, each identified solely by a code. The experimental product was enriched with lactoferrin during the manufacturing process (100mg/125g).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Torino, Torino, Italy, 10126
      • AOU Città della Salute e della Scienza di Torino, University of Torino, Torino.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of GDM confirmed by 75g glucose oral glucose tolerance test (OGTT).
• Caucasian ethnicity, gestational age between 24 and 30 weeks.
• Age >18 and <50 years.
• Body Mass Index (BMI) between 22.5 and 35 kg/m².
• Ability to provide informed consent to participate in the study.

Exclusion Criteria:

• Type 1 diabetes mellitus.
• Allergies to milk proteins or lactose intolerance.
• Known anemia.
• Twin pregnancy.
• Pre-existing iron supplementation exceeding 30 mg/day.
• Insulin therapy at the time of enrollment.
• Any condition or disease requiring specific dietary treatments.
• Concurrent physical or mental conditions requiring pharmacological therapy
• Autoimmune disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactoferrin enriched-yogurt; In this arm participants were randomized to receved a lactoferrin-enriched yogurt (100mg/125g) twice a day for two months.	Dietary supplement: Lactoferrin-enriched yogurt supplementation; Women were randomized to receive the lactoferrin-enriched yogurt (experimental arm, n=25) - (100mg/125g) 2 times a day for 2 months.Yogurt derived from high-quality cow's milk, with the same color, flavor, and texture as the control group yogurt not enriched with lactoferrin. All women of the group received nutritional guidance in accordance with dietary guidelines that accounted for the macronutrient contribution provided by 250g/day of yogurt. The products were provided in unlabeled white plastic cups, distinguishable only by a unique code.
Other: Non-enriched yogurt; In this arm participants were randomized to received a non-enriched yogurt(125g) twice a day for two months.	Dietary supplement: Non-enriched yogurt; Participants were randomized to receved a non-enriched yogurt (125g)- (control arm) twice a day for 2 months. The yogurt was produced from high-quality semi-skimmed cow's milk and It was identical in color, taste, texture, and packaging to the experimental yogurt which conteins lactoferrin. The products were provided in unlabeled white plastic cups, distinguishable only by a unique code.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum ferritin levels after consumption of lactoferrin-enriched yogurt compared to the non-enriched control yogurt.	8 weeks - The change in serum ferritin concentration was assessed from baseline to the end of the intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Hemoglobin concentration. (HGB) [g/dL]	The unit of measure for hemoglobin concentration is grams per deciliter (g/dL).	8 weeks
Occurrence of adverse maternal outcomes [number and percentage of participants]	The unit of measure is the number and percentage (%) of participants with at least one adverse maternal event (yes/no).	8 weeks
Changes in Hematocrit values. (HCT) [%]	The unit of measure for hematocrit values is percent (%).	8 weeks
Changes in Red Blood Cells count. (RBC) [×10⁶/µL]	The unit of measure for red blood cell count is ×10⁶ per microliter (µL).	8 WEEKS
Changes in serum Iron levels. [µg/dL]	The unit of measure for serum iron levels is micrograms per deciliter (µg/dL).	8 weeks
Changes in Transferrin levels. [mg/dL]	The unit of measure for transferrin levels is milligrams per deciliter (mg/dL).	8 weeks
Change in Total Iron-Binding Capacity (TIBC) [µg/dL]	The unit of measure for TIBC is micrograms per deciliter (µg/dL)	8 weeks
Change in Transferrin Saturation. [%]	The unit of measure for transferrin saturation is percent (%).	8 weeks
Change in fasting blood glucose concentration (metabolic variables) [mg/dL]	The unit of measure for glucose concentration is milligrams per deciliter (mg/dL).	8 weeks
Change in fasting serum insulin levels (metabolic variables) [mIU/L]	The unit of measure for insulin is milli-international units per liter (mIU/L).	8 weeks
Occurrence of adverse neonatal outcomes [number and percentage of participants]	The unit of measure is the number and percentage (%) of neonates with at least one adverse neonatal outcome (yes/no).	At delivery
Changes in the maternal gut microbiota composition. [%]	The unit of measure is the relative abundance (%) of bacterial taxa identified by 16S rRNA gene sequencing.	8 weeks

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Simona Bo, Associate Professor, MD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Lactoferrin; Gestational Diabetes Mellitus; Iron status in pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: LACTO_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No