Lactoferrin-enriched Dairy Product in Gestational Diabetes

NCT07287384 | Completed

• 1 other identifier: LACTO_2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes Mellitus; Lactoferrin; Iron status in pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Changes in Hemoglobin concentration. (HGB) [g/dL]

  8 weeks

• Occurrence of adverse maternal outcomes [number and percentage of participants]

  8 weeks

• Changes in Hematocrit values. (HCT) [%]

  8 weeks

• Changes in Red Blood Cells count. (RBC) [×10⁶/µL]

  8 WEEKS

• Changes in serum Iron levels. [µg/dL]

  8 weeks

Study Arms (2)

Lactoferrin enriched-yogurt

EXPERIMENTAL

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

Non-enriched yogurt

OTHER

In this arm participants were randomized to received a non-enriched yogurt(125g) twice a day for two months.

Dietary Supplement: Non-enriched yogurt

Interventions

Lactoferrin-enriched yogurt supplementation DIETARY_SUPPLEMENT

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.

Lactoferrin enriched-yogurt

Non-enriched yogurt DIETARY_SUPPLEMENT

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.

Non-enriched yogurt

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

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

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Simona Bo, Associate Professor, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 17, 2025
• Study Start: March 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)