Dairy Intervention in People With Obesity (DIPO)

Medical University of Graz

Status: Unknown

Conditions: Obesity

Treatments: Dietary Supplement: standard diet; Dietary Supplement: dairy diet; Dietary Supplement: yogurt diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04154475

DIPO 1.0

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

yogurt diet

Experimental group

Description:

yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)

Treatment:

Dietary Supplement: yogurt diet

dairy diet

Active Comparator group

Description:

dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products

Treatment:

Dietary Supplement: dairy diet

standard diet

Active Comparator group

Description:

standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt

Treatment:

Dietary Supplement: standard diet