Dairy Intervention in People With Obesity (DIPO)

June 17, 2020 updated by: Medical University of Graz

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: yogurt diet
yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)
Dietary supplement: yogurt diet
500 g yogurt/day
Active Comparator: dairy diet
dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products
Dietary supplement: dairy diet
500 g non-yogurt dairy products
Active Comparator: standard diet
standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt
Dietary supplement: standard diet
500 g soya-yogurt

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fat mass
Time Frame: 12 weeks
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 12 weeks
body weight [kg]
12 weeks
BMI
Time Frame: 12 weeks
BMI [kg/m²]
12 weeks
waist circumference
Time Frame: 12 weeks
waist circumference [cm]
12 weeks
hip circumference
Time Frame: 12 weeks
hip circumference [cm]
12 weeks
Systolic blood pressure
Time Frame: 12 weeks
systolic blood pressure [mm Hg]
12 weeks
Diastolic blood pressure
Time Frame: 12 weeks
diastolic blood pressure [mm Hg]
12 weeks
Body composition-lean mass
Time Frame: 12 weeks
lean mass [kg]
12 weeks
Body composition-total body fat
Time Frame: 12 weeks
total body fat ([%]
12 weeks
Body composition-gynoid fat mass
Time Frame: 12 weeks
gynoid fat mass [kg]
12 weeks
Body composition-android fat mass
Time Frame: 12 weeks
android fat mass [kg]
12 weeks
AUCglucose
Time Frame: 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose
12 weeks
AUCinsulin
Time Frame: 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin
12 weeks
HOMA-IR
Time Frame: 12 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
12 weeks
HOMA-beta
Time Frame: 12 weeks
insulin sensitivity assessed by HOMA-beta
12 weeks
MATSUDA
Time Frame: 12 weeks
insulin sensitivity assessed by MATSUDA-index
12 weeks
QUICKI
Time Frame: 12 weeks
insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
12 weeks
Total cholesterol
Time Frame: 12 weeks
Total cholesterol [mg/dl]
12 weeks
LDL cholesterol
Time Frame: 12 weeks
LDL cholesterol [mg/dl]
12 weeks
HDL cholesterol
Time Frame: 12 weeks
HDL cholesterol [mg/dl]
12 weeks
Triglycerides
Time Frame: 12 weeks
Triglycerides [mg/dl]
12 weeks
HbA1c
Time Frame: 12 weeks
HbA1c [mmol/mol]
12 weeks
Total testosterone
Time Frame: 12 weeks
Total testosterone [nmol/l]
12 weeks
Free testosterone
Time Frame: 12 weeks
Free testosterone [nmol/l]
12 weeks
Free androgen index
Time Frame: 12 weeks
FAI (Free androgen index)
12 weeks
androstenedione
Time Frame: 12 weeks
androstenedione [nmol/l]
12 weeks
DHEAS
Time Frame: 12 weeks
dehydroepiandrosterone sulfate (DHEAS) [µmol/L]
12 weeks
stool microbiome
Time Frame: 12 weeks
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.
12 weeks
Satiety
Time Frame: 12 weeks
assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.
12 weeks
Food craving
Time Frame: 12 weeks
assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.
12 weeks
Quality of life during weight reduction
Time Frame: 12 weeks
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.
12 weeks
Compliance
Time Frame: 12 weeks
assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisabeth Lerchbaum, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIPO 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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