Clinical trial NCT04154475: Dairy Intervention in People With Obesity
Official title: Dairy Intervention in People With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: yogurt
dairy
calcium
weight reduction
obesity
randomized controlled trial
body composition
microbiome
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: fat mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: BMI
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: hip circumference
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
measure: Body composition-lean mass
timeFrame: 12 weeks
measure: Body composition-total body fat
timeFrame: 12 weeks
measure: Body composition-gynoid fat mass
timeFrame: 12 weeks
measure: Body composition-android fat mass
timeFrame: 12 weeks
measure: AUCglucose
timeFrame: 12 weeks
measure: AUCinsulin
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
measure: HOMA-beta
timeFrame: 12 weeks
measure: MATSUDA
timeFrame: 12 weeks
measure: QUICKI
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks
measure: Total testosterone
timeFrame: 12 weeks
measure: Free testosterone
timeFrame: 12 weeks
measure: Free androgen index
timeFrame: 12 weeks
measure: androstenedione
timeFrame: 12 weeks
measure: DHEAS
timeFrame: 12 weeks
measure: stool microbiome
timeFrame: 12 weeks
measure: Satiety
timeFrame: 12 weeks
measure: Food craving
timeFrame: 12 weeks
measure: Quality of life during weight reduction
timeFrame: 12 weeks
measure: Compliance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Study officials:
affiliation: Medical University of Graz
name: Elisabeth Lerchbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: