ObesityDIPONCT04154475
Dairy Intervention in People With Obesity
A study testing yogurt diet, dairy diet and standard diet in people with Obesity, run by Medical University of Graz at 1 site in Austria.
Trial summary
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- yogurt diet, dairy diet and standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2020to Dec 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥30 kg/m²
- Age of ≥18 and <60 years
- Written informed consent before study entry
- Willingness to introduce a dietary change to lose weight
Who cannot join
- Serum calcium ≥2.7 mmol/l
- Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products
- Pregnancy or lactating women
- Having given birth in the last year or planning a pregnancy in the next 6 months
- Menopause (as defined by FSH levels ≥30 IU/l)
- Disorders associated with androgen excess and/or menstrual irregularities except PCOS (overt thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
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- Malabsorption syndrome
- Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, …), obesity pharmacotherapeutic agents, or calcium supplements in the last 3 months before study entry
- Regular intake of calcium supplements in the last 3 months before study entry
- Lifestyle changes (changes in physical activity) or weight reduction (≥10% of body weight) in the last 3 months before study entry
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Graz, 8036
About this study
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):
- Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d,
- Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d
- Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.
- Conditions
- Obesity
- Being tested
- yogurt diet, dairy diet, standard diet
- Keywords
- yogurt, dairy, calcium, weight reduction, obesity, randomized controlled trial, body composition, microbiome
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogurt dietDietary supplement
500 g yogurt/day
dairy dietDietary supplement
500 g non-yogurt dairy products
standard dietDietary supplement
500 g soya-yogurt
| Study group | Role | What they receive |
|---|---|---|
| yogurt diet | Experimental | yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium) Receives: Dietary Supplement: yogurt diet |
| dairy diet | Active comparator | dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products Receives: Dietary Supplement: dairy diet |
| standard diet | Active comparator | standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt Receives: Dietary Supplement: standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat mass
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).
Measured: 12 weeks
Secondary outcomes (31)
Body weight
body weight [kg]
Measured: 12 weeks
BMI
BMI [kg/m²]
Measured: 12 weeks
waist circumference
waist circumference [cm]
Measured: 12 weeks
hip circumference
hip circumference [cm]
Measured: 12 weeks
Systolic blood pressure
systolic blood pressure [mm Hg]
Measured: 12 weeks
Diastolic blood pressure
diastolic blood pressure [mm Hg]
Measured: 12 weeks
Body composition-lean mass
lean mass [kg]
Measured: 12 weeks
Body composition-total body fat
total body fat ([%]
Measured: 12 weeks
Body composition-gynoid fat mass
gynoid fat mass [kg]
Measured: 12 weeks
Body composition-android fat mass
android fat mass [kg]
Measured: 12 weeks
AUCglucose
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose
Measured: 12 weeks
AUCinsulin
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin
Measured: 12 weeks
HOMA-IR
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Measured: 12 weeks
HOMA-beta
insulin sensitivity assessed by HOMA-beta
Measured: 12 weeks
MATSUDA
insulin sensitivity assessed by MATSUDA-index
Measured: 12 weeks
QUICKI
insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Measured: 12 weeks
Total cholesterol
Total cholesterol [mg/dl]
Measured: 12 weeks
LDL cholesterol
LDL cholesterol [mg/dl]
Measured: 12 weeks
HDL cholesterol
HDL cholesterol [mg/dl]
Measured: 12 weeks
Triglycerides
Triglycerides [mg/dl]
Measured: 12 weeks
HbA1c
HbA1c [mmol/mol]
Measured: 12 weeks
Total testosterone
Total testosterone [nmol/l]
Measured: 12 weeks
Free testosterone
Free testosterone [nmol/l]
Measured: 12 weeks
Free androgen index
FAI (Free androgen index)
Measured: 12 weeks
androstenedione
androstenedione [nmol/l]
Measured: 12 weeks
DHEAS
dehydroepiandrosterone sulfate (DHEAS) [µmol/L]
Measured: 12 weeks
stool microbiome
Composition of the stool microbiome Microbiome analysis will be performed through the following steps: patient collection and provision of a stool specimen, DNA isolation from the specimen, PCR reaction to amplify the selected region of the 16S rRNA gene (only present in bacteria), sequencing of the amplicons using next-generation sequencing technology, bioinformatics processing and analysis of the data using suitable software.
Measured: 12 weeks
Satiety
assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.
Measured: 12 weeks
Food craving
assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.
Measured: 12 weeks
Quality of life during weight reduction
Quality of life assessed via visual analogue scale [VAS]: "How is your quality of life during weight reduction?", minimum score 0, maximum score 10, higher scores mean a better outcome.
Measured: 12 weeks
Compliance
assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study startSep 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Lerchbaum, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154475
- Sponsor's protocol ID
- DIPO 1.0
- Acronym
- DIPO
- Status last verified
- Jun 2020
- First submitted
- 16 Oct 2019
- Last updated
- 18 Jun 2020
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Intervention in People With Obesity
- ClinicalTrials.gov ID
- NCT04154475
- Acronym / sponsor ID
- DIPO / DIPO 1.0
- Conditions
- Obesity
- Keywords
- yogurt, dairy, calcium, weight reduction, obesity, randomized controlled trial, body composition, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Nov 2019 (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.
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):
- Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d,
- Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d
- Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| yogurt diet | Experimental | Dietary Supplement: yogurt dietyogurt-diet (-500 kcal/day, 500 g yogurt, high calcium) |
| dairy diet | Active comparator | Dietary Supplement: dairy dietdairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products |
| standard diet | Active comparator | Dietary Supplement: standard dietstandard diet: -500 kcal/day, low calcium, 500 g soya-yogurt |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥30 kg/m²
- Age of ≥18 and <60 years
- Written informed consent before study entry
- Willingness to introduce a dietary change to lose weight
Key exclusion criteria (10 listed)
- Serum calcium ≥2.7 mmol/l
- Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products
- Pregnancy or lactating women
- Having given birth in the last year or planning a pregnancy in the next 6 months
- Menopause (as defined by FSH levels ≥30 IU/l)
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 |
|---|---|---|
| yogurt diet500 g yogurt/day | Dietary supplement | yogurt diet |
| dairy diet500 g non-yogurt dairy products | Dietary supplement | dairy diet |
| standard diet500 g soya-yogurt | Dietary supplement | standard diet |
Primary outcome
fat mass
Time frame: 12 weeks
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).
31 secondary outcomes
Body weight
Time frame: 12 weeks
BMI
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
hip circumference
Time frame: 12 weeks
Systolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: 12 weeks
Body composition-lean mass
Time frame: 12 weeks
Body composition-total body fat
Time frame: 12 weeks
Body composition-gynoid fat mass
Time frame: 12 weeks
Body composition-android fat mass
Time frame: 12 weeks
AUCglucose
Time frame: 12 weeks
AUCinsulin
Time frame: 12 weeks
HOMA-IR
Time frame: 12 weeks
HOMA-beta
Time frame: 12 weeks
MATSUDA
Time frame: 12 weeks
QUICKI
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
LDL cholesterol
Time frame: 12 weeks
HDL cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
Total testosterone
Time frame: 12 weeks
Free testosterone
Time frame: 12 weeks
Free androgen index
Time frame: 12 weeks
androstenedione
Time frame: 12 weeks
DHEAS
Time frame: 12 weeks
stool microbiome
Time frame: 12 weeks
Satiety
Time frame: 12 weeks
Food craving
Time frame: 12 weeks
Quality of life during weight reduction
Time frame: 12 weeks
Compliance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- 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.
Elisabeth Lerchbaum, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yogurt diet, dairy diet and standard diet in people with Obesity, run by Medical University of Graz at 1 site in Austria.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Jun 2020. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Lerchbaum, MD (0043 316 385 12383, elisabeth.lerchbaum@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat mass (time frame: 12 weeks). 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 18 Jun 2020.