Gestational Diabetes Mellitus (GDM)NCT07287384
Lactoferrin-enriched Dairy Product in Gestational Diabetes
A study testing Lactoferrin-enriched yogurt supplementation and Non-enriched yogurt in people with Gestational Diabetes Mellitus (GDM), run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Lactoferrin-enriched yogurt supplementation and Non-enriched yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Any condition or disease requiring specific dietary treatments.
- Concurrent physical or mental conditions requiring pharmacological therapy
- Autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Città della Salute e della Scienza di Torino, University of Torino, Torino.
Torino, Torino, 10126
About this study
Official title: 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.
Read the 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).
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Lactoferrin-enriched yogurt supplementation, Non-enriched yogurt
- Keywords
- Gestational Diabetes Mellitus, Lactoferrin, Iron status in pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin-enriched yogurt supplementationDietary 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.
Non-enriched yogurtDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin enriched-yogurt | Experimental | In this arm participants were randomized to receved a lactoferrin-enriched yogurt (100mg/125g) twice a day for two months. Receives: 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. Receives: Dietary Supplement: Non-enriched yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin levels after consumption of lactoferrin-enriched yogurt compared to the non-enriched control yogurt.
Measured: 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]
The unit of measure for hemoglobin concentration is grams per deciliter (g/dL).
Measured: 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).
Measured: 8 weeks
Changes in Hematocrit values. (HCT) [%]
The unit of measure for hematocrit values is percent (%).
Measured: 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).
Measured: 8 WEEKS
Changes in serum Iron levels. [µg/dL]
The unit of measure for serum iron levels is micrograms per deciliter (µg/dL).
Measured: 8 weeks
Changes in Transferrin levels. [mg/dL]
The unit of measure for transferrin levels is milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in Total Iron-Binding Capacity (TIBC) [µg/dL]
The unit of measure for TIBC is micrograms per deciliter (µg/dL)
Measured: 8 weeks
Change in Transferrin Saturation. [%]
The unit of measure for transferrin saturation is percent (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Mar 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
- Investigators
- Simona Bo, Associate Professor, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287384
- Sponsor's protocol ID
- LACTO_2025
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dairy Product Enriched With Lactoferrin on Iron Status of Women With Gestational Diabetes. A Pilot Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT07287384
- Acronym / sponsor ID
- LACTO_2025
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus, Lactoferrin, Iron status in pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin enriched-yogurt | Experimental | Dietary Supplement: Lactoferrin-enriched yogurt supplementationIn this arm participants were randomized to receved a lactoferrin-enriched yogurt (100mg/125g) twice a day for two months. |
| Non-enriched yogurt | Other | Dietary Supplement: Non-enriched yogurtIn this arm participants were randomized to received a non-enriched yogurt(125g) twice a day for two months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus.
- Allergies to milk proteins or lactose intolerance.
- Known anemia.
- Twin pregnancy.
- Pre-existing iron supplementation exceeding 30 mg/day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin-enriched yogurt supplementationWomen 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 | Lactoferrin enriched-yogurt |
| Non-enriched yogurtParticipants 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. | Dietary supplement | Non-enriched yogurt |
Primary outcome
Change in serum ferritin levels after consumption of lactoferrin-enriched yogurt compared to the non-enriched control yogurt.
Time frame: 8 weeks - The change in serum ferritin concentration was assessed from baseline to the end of the intervention period.
12 secondary outcomes
Changes in Hemoglobin concentration. (HGB) [g/dL]
Time frame: 8 weeks
Occurrence of adverse maternal outcomes [number and percentage of participants]
Time frame: 8 weeks
Changes in Hematocrit values. (HCT) [%]
Time frame: 8 weeks
Changes in Red Blood Cells count. (RBC) [×10⁶/µL]
Time frame: 8 WEEKS
Changes in serum Iron levels. [µg/dL]
Time frame: 8 weeks
Changes in Transferrin levels. [mg/dL]
Time frame: 8 weeks
Change in Total Iron-Binding Capacity (TIBC) [µg/dL]
Time frame: 8 weeks
Change in Transferrin Saturation. [%]
Time frame: 8 weeks
Change in fasting blood glucose concentration (metabolic variables) [mg/dL]
Time frame: 8 weeks
Change in fasting serum insulin levels (metabolic variables) [mIU/L]
Time frame: 8 weeks
Occurrence of adverse neonatal outcomes [number and percentage of participants]
Time frame: At delivery
Changes in the maternal gut microbiota composition. [%]
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Bo, Associate Professor, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin-enriched yogurt supplementation and Non-enriched yogurt in people with Gestational Diabetes Mellitus (GDM), run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum ferritin levels after consumption of lactoferrin-enriched yogurt compared to the non-enriched control yogurt. (time frame: 8 weeks - The change in serum ferritin concentration was assessed from baseline to the end of the intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.