Lactoferrin-enriched Dairy Product in Gestational Diabetes

University of Turin

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Dietary Supplement: Lactoferrin-enriched yogurt supplementation; Dietary Supplement: Non-enriched yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT07287384

LACTO_2025

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Lactoferrin enriched-yogurt

Experimental group

Description:

In this arm participants were randomized to receved a lactoferrin-enriched yogurt (100mg/125g) twice a day for two months.

Treatment:

Dietary Supplement: Lactoferrin-enriched yogurt supplementation

Non-enriched yogurt

Other group

Description:

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

Treatment:

Dietary Supplement: Non-enriched yogurt