Dairy Intervention in People With Obesity

Obesity Clinical Trial

— DIPO  

Official title:

Dairy Intervention in People With Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04154475
• Other study ID #: DIPO 1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Medical University of Graz
• Contact: Elisabeth Lerchbaum, MD
• Phone: 0043 316 385 12383
• Email: elisabeth.lerchbaum[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• yogurt diet
500 g yogurt/day
• dairy diet
500 g non-yogurt dairy products
• standard diet
500 g soya-yogurt

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

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