NCT04154475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

October 16, 2019

Last Update Submit

June 17, 2020

Conditions

Obesity

Keywords

yogurtdairycalciumweight reductionobesityrandomized controlled trialbody compositionmicrobiome

Outcome Measures

Primary Outcomes (1)

  • fat mass

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

    12 weeks

Secondary Outcomes (31)

  • Body weight

    12 weeks

  • BMI

    12 weeks

  • waist circumference

    12 weeks

  • hip circumference

    12 weeks

  • Systolic blood pressure

    12 weeks

  • +26 more secondary outcomes

Study Arms (3)

yogurt diet

EXPERIMENTAL

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

Dietary Supplement: yogurt diet

dairy diet

ACTIVE COMPARATOR

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

Dietary Supplement: dairy diet

standard diet

ACTIVE COMPARATOR

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

Dietary Supplement: standard diet

Interventions

yogurt dietDIETARY_SUPPLEMENT

500 g yogurt/day

yogurt diet
dairy dietDIETARY_SUPPLEMENT

500 g non-yogurt dairy products

dairy diet
standard dietDIETARY_SUPPLEMENT

500 g soya-yogurt

standard diet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism

Graz, 8036, Austria

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Elisabeth Lerchbaum, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Lerchbaum, MD

CONTACT

0043 316 385 12383elisabeth.lerchbaum@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

November 6, 2019

Study Start

September 1, 2020

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)