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Dairy Intervention in People With Obesity (DIPO)

M

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)

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

Trial contacts and locations

1

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Central trial contact

Elisabeth Lerchbaum, MD

Data sourced from clinicaltrials.gov

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