Dairy Intervention in People With Obesity

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: yogurt diet; Dietary Supplement: dairy diet; Dietary Supplement: standard diet

• Registration Number: NCT04154475
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18
• Study Start: 2020-09
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
yogurt diet	yogurt diet	yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)
dairy diet	dairy diet	dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products
standard diet	standard diet	standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism; 🇦🇹 Graz, Austria