Dairy Intervention in People With Obesity (DIPO)

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: Unknown
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: yogurt diet; Dietary supplement: dairy diet; Dietary supplement: standard diet

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Lerchbaum, MD; Phone Number: 0043 316 385 12383; Email: elisabeth.lerchbaum@medunigraz.at

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	body weight [kg]	12 weeks
BMI	BMI [kg/m²]	12 weeks
waist circumference	waist circumference [cm]	12 weeks
hip circumference	hip circumference [cm]	12 weeks
Systolic blood pressure	systolic blood pressure [mm Hg]	12 weeks
Diastolic blood pressure	diastolic blood pressure [mm Hg]	12 weeks
Body composition-lean mass	lean mass [kg]	12 weeks
Body composition-total body fat	total body fat ([%]	12 weeks
Body composition-gynoid fat mass	gynoid fat mass [kg]	12 weeks
Body composition-android fat mass	android fat mass [kg]	12 weeks
AUCglucose	Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose	12 weeks
AUCinsulin	Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin	12 weeks
HOMA-IR	Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)	12 weeks
HOMA-beta	insulin sensitivity assessed by HOMA-beta	12 weeks
MATSUDA	insulin sensitivity assessed by MATSUDA-index	12 weeks
QUICKI	insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)	12 weeks
Total cholesterol	Total cholesterol [mg/dl]	12 weeks
LDL cholesterol	LDL cholesterol [mg/dl]	12 weeks
HDL cholesterol	HDL cholesterol [mg/dl]	12 weeks
Triglycerides	Triglycerides [mg/dl]	12 weeks
HbA1c	HbA1c [mmol/mol]	12 weeks
Total testosterone	Total testosterone [nmol/l]	12 weeks
Free testosterone	Free testosterone [nmol/l]	12 weeks
Free androgen index	FAI (Free androgen index)	12 weeks
androstenedione	androstenedione [nmol/l]	12 weeks
DHEAS	dehydroepiandrosterone sulfate (DHEAS) [µmol/L]	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.	12 weeks
Satiety	assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.	12 weeks
Food craving	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	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	assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Elisabeth Lerchbaum, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; obesity; body composition; microbiome; yogurt; dairy; calcium; weight reduction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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