Dairy Intervention in People With Obesity

Medical University of Graz120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Obesity

Interventions

yogurt dietDIETARY_SUPPLEMENT

500 g yogurt/day

dairy dietDIETARY_SUPPLEMENT

500 g non-yogurt dairy products

standard dietDIETARY_SUPPLEMENT

500 g soya-yogurt

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Graz, Austria

Outcomes

Primary Outcomes

fat mass

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

Time frame: 12 weeks

Secondary Outcomes

Body weight

body weight \[kg\]

Time frame: 12 weeks

BMI

BMI \[kg/m²\]

Time frame: 12 weeks

waist circumference

waist circumference \[cm\]

Time frame: 12 weeks

hip circumference

hip circumference \[cm\]

Time frame: 12 weeks

Systolic blood pressure

systolic blood pressure \[mm Hg\]

Time frame: 12 weeks

Diastolic blood pressure

diastolic blood pressure \[mm Hg\]

Time frame: 12 weeks

Body composition-lean mass

lean mass \[kg\]

Time frame: 12 weeks

Body composition-total body fat

total body fat (\[%\]

Time frame: 12 weeks

Body composition-gynoid fat mass

gynoid fat mass \[kg\]

Central Contacts

Elisabeth Lerchbaum, MD

CONTACT

0043 316 385 12383 elisabeth.lerchbaum@medunigraz.at

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 12 weeks

Body composition-android fat mass

android fat mass \[kg\]

Time frame: 12 weeks

AUCglucose

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose

Time frame: 12 weeks

AUCinsulin

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin

Time frame: 12 weeks

HOMA-IR

Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

Time frame: 12 weeks

HOMA-beta

insulin sensitivity assessed by HOMA-beta

Time frame: 12 weeks

MATSUDA

insulin sensitivity assessed by MATSUDA-index

Time frame: 12 weeks

QUICKI

insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)

Time frame: 12 weeks

Total cholesterol

Total cholesterol \[mg/dl\]

Time frame: 12 weeks

LDL cholesterol

LDL cholesterol \[mg/dl\]

Time frame: 12 weeks

HDL cholesterol

HDL cholesterol \[mg/dl\]

Time frame: 12 weeks

Triglycerides

Triglycerides \[mg/dl\]

Time frame: 12 weeks

HbA1c

HbA1c \[mmol/mol\]

Time frame: 12 weeks

Total testosterone

Total testosterone \[nmol/l\]

Time frame: 12 weeks

Free testosterone

Free testosterone \[nmol/l\]

Time frame: 12 weeks

Free androgen index

FAI (Free androgen index)

Time frame: 12 weeks

androstenedione

androstenedione \[nmol/l\]

Time frame: 12 weeks

DHEAS

dehydroepiandrosterone sulfate (DHEAS) \[µmol/L\]

Time frame: 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.

Time frame: 12 weeks

Satiety

assessed via visual analogue scale \[VAS\]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.

Time frame: 12 weeks

Food craving

assessed via visual analogue scale \[VAS\]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.

Time frame: 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.

Time frame: 12 weeks

Compliance

assessed via visual analogue scale \[VAS\]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.

Time frame: 12 weeks