Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01726647
Other study ID # 08.02.NRC
Secondary ID
Status Completed
Phase N/A
First received November 6, 2012
Last updated November 9, 2012
Start date September 2008
Est. completion date April 2012

Study information

Verified date November 2012
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Objectives:

The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).

No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2012
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- BMI 29-40 kg/m2

- Aged 25-45

Exclusion Criteria:

- Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome

- Pregnancy

- Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.

- Any therapy (contraception apart) within the run-in period of one week before the test day.

- Subject who cannot be expected to comply with treatments and measures.

- Subject who is affected by any specific eating disorder

- Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.

- Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Hospitals, Service of endocrinology, diabetology, and metabolism Lausanne
Switzerland Nestlé Clinical Development Unit / Metabolic Unit Lausanne 26

Sponsors (2)

Lead Sponsor Collaborator
Nestlé University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic plasma, urine and faeces profiles as a function of fat mass distribution Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry.
Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).
Changes from baseline in metabolic profiles at one day following fat meal intake No
Secondary Insulin sensitivity Insulin sensitivity is measured by oral glucose tolerance test Measured on the day before the fat meal intake No
Secondary Basal Energy Expenditure Basal Energy Expenditure is measured by indirect calorimetry Basal Energy Expenditure is measured on the day preceding the fat meal intake No
See also
  Status Clinical Trial Phase
Completed NCT04105075 - COPD in Obese Patients
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Recruiting NCT05857150 - Exercise Response in Humans With Obesity
Completed NCT03532672 - Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT02618486 - The Effects of Obesity on Non Surgical Periodontal Therapy N/A
Completed NCT01724515 - PGC-1 and Mitochondrial Dysfunction in Diabetes N/A
Completed NCT01724502 - Mitochondrial Dysfunction in Diabetes N/A
Active, not recruiting NCT01634204 - Efficacy of a Web-based Weight Loss Program Phase 2
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT01421589 - Growth Hormone Treatment on Phosphocreatine Recovery in Obesity N/A
Completed NCT03528304 - Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss N/A
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Active, not recruiting NCT02125149 - The Expecting Study N/A
Completed NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects Phase 1
Completed NCT05433506 - Safety and Pharmacokinetics of HU6 Phase 1
Completed NCT02871882 - Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus Phase 2
Completed NCT03298464 - Study of NGM313 in Obese Participants Phase 1
Completed NCT05061173 - Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults N/A
Completed NCT02919176 - Brown Fat Activation Study Early Phase 1