search
Back to results

Dairy Intervention in People With Obesity (DIPO)

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
yogurt diet
dairy diet
standard diet
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring yogurt, dairy, calcium, weight reduction, obesity, randomized controlled trial, body composition, microbiome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

yogurt diet

dairy diet

standard diet

Arm Description

yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)

dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products

standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt

Outcomes

Primary Outcome Measures

fat mass
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).

Secondary Outcome Measures

Body weight
body weight [kg]
BMI
BMI [kg/m²]
waist circumference
waist circumference [cm]
hip circumference
hip circumference [cm]
Systolic blood pressure
systolic blood pressure [mm Hg]
Diastolic blood pressure
diastolic blood pressure [mm Hg]
Body composition-lean mass
lean mass [kg]
Body composition-total body fat
total body fat ([%]
Body composition-gynoid fat mass
gynoid fat mass [kg]
Body composition-android fat mass
android fat mass [kg]
AUCglucose
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose
AUCinsulin
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin
HOMA-IR
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
HOMA-beta
insulin sensitivity assessed by HOMA-beta
MATSUDA
insulin sensitivity assessed by MATSUDA-index
QUICKI
insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Total cholesterol
Total cholesterol [mg/dl]
LDL cholesterol
LDL cholesterol [mg/dl]
HDL cholesterol
HDL cholesterol [mg/dl]
Triglycerides
Triglycerides [mg/dl]
HbA1c
HbA1c [mmol/mol]
Total testosterone
Total testosterone [nmol/l]
Free testosterone
Free testosterone [nmol/l]
Free androgen index
FAI (Free androgen index)
androstenedione
androstenedione [nmol/l]
DHEAS
dehydroepiandrosterone sulfate (DHEAS) [µmol/L]
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.
Satiety
assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.
Food craving
assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.
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.
Compliance
assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.

Full Information

First Posted
October 16, 2019
Last Updated
June 17, 2020
Sponsor
Medical University of Graz
search

1. Study Identification

Unique Protocol Identification Number
NCT04154475
Brief Title
Dairy Intervention in People With Obesity
Acronym
DIPO
Official Title
Dairy Intervention in People With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
yogurt, dairy, calcium, weight reduction, obesity, randomized controlled trial, body composition, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
yogurt diet
Arm Type
Experimental
Arm Description
yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)
Arm Title
dairy diet
Arm Type
Active Comparator
Arm Description
dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products
Arm Title
standard diet
Arm Type
Active Comparator
Arm Description
standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt
Intervention Type
Dietary Supplement
Intervention Name(s)
yogurt diet
Intervention Description
500 g yogurt/day
Intervention Type
Dietary Supplement
Intervention Name(s)
dairy diet
Intervention Description
500 g non-yogurt dairy products
Intervention Type
Dietary Supplement
Intervention Name(s)
standard diet
Intervention Description
500 g soya-yogurt
Primary Outcome Measure Information:
Title
fat mass
Description
Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
body weight [kg]
Time Frame
12 weeks
Title
BMI
Description
BMI [kg/m²]
Time Frame
12 weeks
Title
waist circumference
Description
waist circumference [cm]
Time Frame
12 weeks
Title
hip circumference
Description
hip circumference [cm]
Time Frame
12 weeks
Title
Systolic blood pressure
Description
systolic blood pressure [mm Hg]
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
diastolic blood pressure [mm Hg]
Time Frame
12 weeks
Title
Body composition-lean mass
Description
lean mass [kg]
Time Frame
12 weeks
Title
Body composition-total body fat
Description
total body fat ([%]
Time Frame
12 weeks
Title
Body composition-gynoid fat mass
Description
gynoid fat mass [kg]
Time Frame
12 weeks
Title
Body composition-android fat mass
Description
android fat mass [kg]
Time Frame
12 weeks
Title
AUCglucose
Description
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose
Time Frame
12 weeks
Title
AUCinsulin
Description
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin
Time Frame
12 weeks
Title
HOMA-IR
Description
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time Frame
12 weeks
Title
HOMA-beta
Description
insulin sensitivity assessed by HOMA-beta
Time Frame
12 weeks
Title
MATSUDA
Description
insulin sensitivity assessed by MATSUDA-index
Time Frame
12 weeks
Title
QUICKI
Description
insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Time Frame
12 weeks
Title
Total cholesterol
Description
Total cholesterol [mg/dl]
Time Frame
12 weeks
Title
LDL cholesterol
Description
LDL cholesterol [mg/dl]
Time Frame
12 weeks
Title
HDL cholesterol
Description
HDL cholesterol [mg/dl]
Time Frame
12 weeks
Title
Triglycerides
Description
Triglycerides [mg/dl]
Time Frame
12 weeks
Title
HbA1c
Description
HbA1c [mmol/mol]
Time Frame
12 weeks
Title
Total testosterone
Description
Total testosterone [nmol/l]
Time Frame
12 weeks
Title
Free testosterone
Description
Free testosterone [nmol/l]
Time Frame
12 weeks
Title
Free androgen index
Description
FAI (Free androgen index)
Time Frame
12 weeks
Title
androstenedione
Description
androstenedione [nmol/l]
Time Frame
12 weeks
Title
DHEAS
Description
dehydroepiandrosterone sulfate (DHEAS) [µmol/L]
Time Frame
12 weeks
Title
stool microbiome
Description
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.
Time Frame
12 weeks
Title
Satiety
Description
assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Food craving
Description
assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Quality of life during weight reduction
Description
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.
Time Frame
12 weeks
Title
Compliance
Description
assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Lerchbaum, MD
Phone
0043 316 385 12383
Email
elisabeth.lerchbaum@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Lerchbaum, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dairy Intervention in People With Obesity

We'll reach out to this number within 24 hrs