PrediabetesSNOWFALLNCT06836752
Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects
A study testing Yoghurt and Milk in people with Prediabetes, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Yoghurt and Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2025to 15 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed ICF
- Male/Female 18-65 years
- BMI 25-35 kg/m2
- FPG 100-125 mg/dL
- At least one relative with T2DM
- BW maintained (<3%)
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- Female postmenopausal or sterile or using contraceptive method
- Ability to comply with study protocol form
- Access to a refrigerator at home for study products storage
- Ability to collect and store stool samples
- Coverage by French health insurance
- Agreement to be registered in the national database of subjects participating in clinical research
- Ability to complete ePRO
- FPG 100-125 mg/dL at randomisation visit
Who cannot join
- Diagnosis of T2DM, T1DM, or on antidiabetic medications
- Medications or supplements affecting gut microbiota or causing hyperglycemia
- Systemic antibiotic treatment
- Treatment interfering with BW and bariatric surgery
- Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency
- Chronic gastro-intestinal disorders or recent use of laxatives
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- Recent surgery or general anesthesia
- Donation/Loss of blood
- Inability to comply with dietary restriction
- Allergy or intolerance to study product ingredients
- Excessive consumption of alcohol
- Smoker
- Pregnancy, breast-feeding or change in contraceptive methods
- Situation interfering with optimal participation
- Participation in other clinical study
- Living in the same home as another participant
- Employees, family members of Danone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open Label, Controlled, Parallel-group Study to Explore the Effects of 24 Weeks Intake of Yoghurt on Glucose Metabolism in Subjects at High Risk of Type 2 Diabetes Mellitus
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.
Read the detailed description
Study population: the study population will consist of 60 (30 per group) subjects (men and women) at high risk of type 2 diabetes mellitus (T2DM), aged 18-65 years (inclusive), body mass index (BMI) 25.0 (inclusive) - 35.0 kg/m2 (exclusive), diagnosed with prediabetes, defined as fasting plasma glucose levels 100-125 mg/dL (5.6-6.9 mmol/L) (inclusive), randomised in a test and control group.
Intervention comprises of two study periods: a refrain period from dairy products and pro-, pre- and synbiotic supplements in any form, for 2 weeks, followed by an intervention period of 24 weeks.
- Conditions
- Prediabetes
- Being tested
- Yoghurt, Milk
- Keywords
- Randomized controlled trial, Prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YoghurtOther
250 g per day
MilkOther
250 g per day
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt | Experimental | 2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day. Receives: Other: Yoghurt |
| Milk | Placebo comparator | 2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day. Receives: Other: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated as fasting serum insulin (FSI) levels (mU/L) multiplied by fasting plasma glucose (FPG) levels (mmol/L) divided by 22.5.
Measured: Change from Baseline to Week 24
Change in FPG [mmol/L]
Measured: Change from Baseline to Week 24
Change in 2-h post load Glucose Area Under the Curve (AUC) [mmol/L· min] measured during 2-hour oral glucose tolerance test (OGTT)
Measured: Change from Baseline to Week 24
Secondary outcomes (32)
Change in Body Weight [kg]
Measured: Change from Baseline to Week 12 and to Week 24
Change in Body Mass Index (BMI) [kg/m²] as calculated by body weight (kg) divided by square of height (m)
Measured: Change from Baseline to Week 12 and to Week 24
Change in Waist Circumference [cm]
Measured: Change from Baseline to Week 12 and to Week 24
Change in Fat Mass as measured by Bioelectrical Impedance Analysis (BIA) [kg]
Measured: Change from Baseline to Week 24
Change in Fat Mass Percentage as measured by BIA (%)
Measured: Change from Baseline to Week 24
Change in Visceral Adipose Tissue mass [g] as measured by BIA [g]
Measured: Change from Baseline to Week 24
Change in Fat Free Mass as measured by BIA [kg]
Measured: Change from Baseline to Week 24
Change in fasting plasma Glycated Haemoglobin A1c (HbA1C) [%]
Measured: Change from Baseline to Week 12 and to Week 24
Change in FSI levels [mU/L]
Measured: Change from Baseline to Week 12 and to Week 24
Change in HOMA-IR calculated as FSI (mU/L) multiplied by FPG, (mmol/L) divided by 22.5
Measured: Change from Baseline to Week 12
Change in FPG levels [mmol/L]
Measured: Change from Baseline to Week 12
Change in Glucose tolerance as measured by plasma glucose at 30-, 60-, and 120-min post load during 2-hour OGTT [mmol/L]
Measured: Change from Baseline to Week 24
Change in Insulin secretion as measured by serum insulin at 30-, 60-, and 120-min post load during 2-hour OGTT [mU/L]
Measured: Change from Baseline to Week 24
Change in β-cell function as measured by Homeostatic Model Assessment of β-cell function (HOMA-β) calculated as follows: 20 x FSI levels (mU/L) divided by FPG levels (mmol/L) subtracted by 3.5
Measured: Change from Baseline to Week 24
Change in β-cell response as measured by Insulinogenic index (IGI), calculated from the OGTT as delta serum insulin (0-30 min) (µU/mL) divided by delta plasma glucose (0-30 min) (mg/dL)
Measured: Change from Baseline to Week 24
Change in whole-body insulin sensitivity as measured by Matsuda index, calculated from the OGTT as follows: (10,000/square root of (FPG (mg/dL) x FSI (mU/L)) x (mean plasma glucose (mg/dL) x mean serum insulin (mU/L) during OGTT])
Measured: Change from Baseline to Week 24
Change in Disposition Index (DI), a composite marker of first phase insulin secretion and insulin sensitivity calculated from the OGTT as follows: Matsuda index * [AUC30min serum insulin (pmol/L) / AUC30min plasma glucose (mmol/L)], where AUC30min is the
Measured: Change from Baseline to Week 24
Change in Muscle Insulin Sensitivity Index (MISI), calculated from the OGTT as the slope of the least square fit to the decline in plasma glucose concentration (mmol/L) from peak to nadir divided by the mean serum insulin (pmol/L) during OGTT
Measured: Change from Baseline to Week 24
Change in Hepatic Insulin Resistance Index (HIRI) calculated from the OGTT as follows: the product of the plasma glucose (mmol/L) area under the curve and serum insulin (pmol/L) area under the curve during the first 30min of the OGTT
Measured: Change from Baseline to Week 24
Change in fasting circulating concentrations of alpha-hydroxyisocaproic acid (HICA), alpha-hydroxyisovaleric acid (HIVA) and alpha-hydroxy-beta-methylvaleric acid (HMVA) (μmol/L)
Measured: Change from Baseline to Week 24
Change in plasma Alanine Aminotransferase (ALAT) [U/L])
Measured: Change from Baseline to Week 12 and to Week 24
Change in plasma Aspartate Aminotransferase (ASAT) [U/L])
Measured: Change from Baseline to Week 12 and to Week 24
Change in Fibrosis 4 index (FIB-4) calculated as (Age (years) x ASAT (U/L) / (Platelets (109/L) x square root of ALAT (U/L)))
Measured: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Total Cholesterol (TC) [mmol/L]
Measured: Change from Baseline to Week 12 and to Week 24
Change in fasting serum High Density Lipoprotein (HDL) [mmol/L]
Measured: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Low Density Lipoprotein (LDL) [mmol/L]
Measured: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Triglycerides (TG) [mmol/L]
Measured: Change from Baseline to Week 12 and to Week 24
Change in Energy intake from 3 non-consecutives days of 24-h dietary recalls [kcal/day]
Measured: Change from Baseline to Week 12 and to Week 24
Change in macronutrients intake from 3 non-consecutives days of 24-h dietary recalls [g/day]
Measured: Change from Baseline to Week 12 and to Week 24
Change in physical activity energy expenditure score as measured by Recent Physical Activity Questionnaire (Metabolic Equivalent of Task hours/day)
Measured: Change from Baseline to Week 12 and to Week 24
Change in Gut microbiota composition as measured by fecal microbial alpha-diversity, beta diversity and taxa abundances using metagenomic approach
Measured: Change from Baseline to Week 24
Change in Gut microbiota function as measured by fecal microbial pathways abundances using metagenomic approach
Measured: Change from Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start16 Sep 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Why it stopped: The current operational setting is not sustainable and very unlikely to deliver the planned enrollment of 60 participants. Even with significant protocol amendments, these challenges would remain.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open label, controlled, parallel-group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836752
- Sponsor's protocol ID
- 23REX0060026
- Acronym
- SNOWFALL
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2025
- Last updated
- 12 Jan 2026
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label, Controlled, Parallel-group Study to Explore the Effects of 24 Weeks Intake of Yoghurt on Glucose Metabolism in Subjects at High Risk of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06836752
- Acronym / sponsor ID
- SNOWFALL / 23REX0060026
- Conditions
- Prediabetes
- Keywords
- Randomized controlled trial, Prediabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The current operational setting is not sustainable and very unlikely to deliver the planned enrollment of 60 participants. Even with significant protocol amendments, these challenges would remain.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 20 Feb 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.
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.
Detailed description
Study population: the study population will consist of 60 (30 per group) subjects (men and women) at high risk of type 2 diabetes mellitus (T2DM), aged 18-65 years (inclusive), body mass index (BMI) 25.0 (inclusive) - 35.0 kg/m2 (exclusive), diagnosed with prediabetes, defined as fasting plasma glucose levels 100-125 mg/dL (5.6-6.9 mmol/L) (inclusive), randomised in a test and control group.
Intervention comprises of two study periods: a refrain period from dairy products and pro-, pre- and synbiotic supplements in any form, for 2 weeks, followed by an intervention period of 24 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open label, controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Yoghurt | Experimental | Other: Yoghurt2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day. |
| Milk | Placebo comparator | Other: Milk2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed ICF
- Male/Female 18-65 years
- BMI 25-35 kg/m2
- FPG 100-125 mg/dL
- At least one relative with T2DM
Key exclusion criteria (17 listed)
- Diagnosis of T2DM, T1DM, or on antidiabetic medications
- Medications or supplements affecting gut microbiota or causing hyperglycemia
- Systemic antibiotic treatment
- Treatment interfering with BW and bariatric surgery
- Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency
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 |
|---|---|---|
| Yoghurt250 g per day | Other | Yoghurt |
| Milk250 g per day | Other | Milk |
Primary outcome
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated as fasting serum insulin (FSI) levels (mU/L) multiplied by fasting plasma glucose (FPG) levels (mmol/L) divided by 22.5.
Time frame: Change from Baseline to Week 24
Change in FPG [mmol/L]
Time frame: Change from Baseline to Week 24
Change in 2-h post load Glucose Area Under the Curve (AUC) [mmol/L· min] measured during 2-hour oral glucose tolerance test (OGTT)
Time frame: Change from Baseline to Week 24
32 secondary outcomes
Change in Body Weight [kg]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Body Mass Index (BMI) [kg/m²] as calculated by body weight (kg) divided by square of height (m)
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Waist Circumference [cm]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Fat Mass as measured by Bioelectrical Impedance Analysis (BIA) [kg]
Time frame: Change from Baseline to Week 24
Change in Fat Mass Percentage as measured by BIA (%)
Time frame: Change from Baseline to Week 24
Change in Visceral Adipose Tissue mass [g] as measured by BIA [g]
Time frame: Change from Baseline to Week 24
Change in Fat Free Mass as measured by BIA [kg]
Time frame: Change from Baseline to Week 24
Change in fasting plasma Glycated Haemoglobin A1c (HbA1C) [%]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in FSI levels [mU/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in HOMA-IR calculated as FSI (mU/L) multiplied by FPG, (mmol/L) divided by 22.5
Time frame: Change from Baseline to Week 12
Change in FPG levels [mmol/L]
Time frame: Change from Baseline to Week 12
Change in Glucose tolerance as measured by plasma glucose at 30-, 60-, and 120-min post load during 2-hour OGTT [mmol/L]
Time frame: Change from Baseline to Week 24
Change in Insulin secretion as measured by serum insulin at 30-, 60-, and 120-min post load during 2-hour OGTT [mU/L]
Time frame: Change from Baseline to Week 24
Change in β-cell function as measured by Homeostatic Model Assessment of β-cell function (HOMA-β) calculated as follows: 20 x FSI levels (mU/L) divided by FPG levels (mmol/L) subtracted by 3.5
Time frame: Change from Baseline to Week 24
Change in β-cell response as measured by Insulinogenic index (IGI), calculated from the OGTT as delta serum insulin (0-30 min) (µU/mL) divided by delta plasma glucose (0-30 min) (mg/dL)
Time frame: Change from Baseline to Week 24
Change in whole-body insulin sensitivity as measured by Matsuda index, calculated from the OGTT as follows: (10,000/square root of (FPG (mg/dL) x FSI (mU/L)) x (mean plasma glucose (mg/dL) x mean serum insulin (mU/L) during OGTT])
Time frame: Change from Baseline to Week 24
Change in Disposition Index (DI), a composite marker of first phase insulin secretion and insulin sensitivity calculated from the OGTT as follows: Matsuda index * [AUC30min serum insulin (pmol/L) / AUC30min plasma glucose (mmol/L)], where AUC30min is the
Time frame: Change from Baseline to Week 24
Change in Muscle Insulin Sensitivity Index (MISI), calculated from the OGTT as the slope of the least square fit to the decline in plasma glucose concentration (mmol/L) from peak to nadir divided by the mean serum insulin (pmol/L) during OGTT
Time frame: Change from Baseline to Week 24
Change in Hepatic Insulin Resistance Index (HIRI) calculated from the OGTT as follows: the product of the plasma glucose (mmol/L) area under the curve and serum insulin (pmol/L) area under the curve during the first 30min of the OGTT
Time frame: Change from Baseline to Week 24
Change in fasting circulating concentrations of alpha-hydroxyisocaproic acid (HICA), alpha-hydroxyisovaleric acid (HIVA) and alpha-hydroxy-beta-methylvaleric acid (HMVA) (μmol/L)
Time frame: Change from Baseline to Week 24
Change in plasma Alanine Aminotransferase (ALAT) [U/L])
Time frame: Change from Baseline to Week 12 and to Week 24
Change in plasma Aspartate Aminotransferase (ASAT) [U/L])
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Fibrosis 4 index (FIB-4) calculated as (Age (years) x ASAT (U/L) / (Platelets (109/L) x square root of ALAT (U/L)))
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Total Cholesterol (TC) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum High Density Lipoprotein (HDL) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Low Density Lipoprotein (LDL) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Triglycerides (TG) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Energy intake from 3 non-consecutives days of 24-h dietary recalls [kcal/day]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in macronutrients intake from 3 non-consecutives days of 24-h dietary recalls [g/day]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in physical activity energy expenditure score as measured by Recent Physical Activity Questionnaire (Metabolic Equivalent of Task hours/day)
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Gut microbiota composition as measured by fecal microbial alpha-diversity, beta diversity and taxa abundances using metagenomic approach
Time frame: Change from Baseline to Week 24
Change in Gut microbiota function as measured by fecal microbial pathways abundances using metagenomic approach
Time frame: Change from Baseline to Week 24
Results and safety
The study was stopped early (reason given: The current operational setting is not sustainable and very unlikely to deliver the planned enrollment of 60 participants. Even with significant protocol amendments, these challenges would remain.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoghurt and Milk in people with Prediabetes, run by Danone Global Research & Innovation Center at 1 site in France.
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 14 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Jan 2026. 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 France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The current operational setting is not sustainable and very unlikely to deliver the planned enrollment of 60 participants. Even with significant protocol amendments, these challenges would remain.). Results are not available in the source record.
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 Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated as fasting serum insulin (FSI) levels (mU/L) multiplied by fasting plasma glucose (FPG) levels (mmol/L) divided by 22.5. (time frame: Change from Baseline to Week 24). The study lists 3 primary outcomes in all. 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 12 Jan 2026.