Lactoferrin-enriched Dairy Product in Gestational Diabetes
NCT ID: NCT07287384
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-03-01
2025-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lactoferrin enriched-yogurt
In this arm participants were randomized to receved a lactoferrin-enriched yogurt (100mg/125g) twice a day for two months.
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.
Non-enriched yogurt
In this arm participants were randomized to received a non-enriched yogurt(125g) twice a day for two months.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Simona Bo
Associate Professor
Principal Investigators
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Simona Bo, Associate Professor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
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AOU Città della Salute e della Scienza di Torino, University of Torino, Torino.
Torino, Torino, Italy
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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LACTO_2025
Identifier Type: -
Identifier Source: org_study_id