MedTrace Logo

Lactoferrin-enriched Dairy Product in Gestational Diabetes

NCT07287384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-17

No results posted yet for this study

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)

Interventions

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.

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Simona Bo, Associate Professor, MD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287384 on ClinicalTrials.gov