Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)

Healthy Clinical Trial

— LIPOGAIN  

Official title:

Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427140
• Other study ID #: SLS-2011-LPG
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: December 8, 2011
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.

Description:

Specific goals:

• Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain

• Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain

• Investigate effects of weight gain and dietary fat composition on markers of vascular health

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• Healthy,

• Body Mass Index 18-27

Exclusion Criteria:

• Liver disease,

• Coronary heart disease,

• Diabetes mellitus,

• Malignant diseases,

• Alcohol or drug abuse,

• Magnetic Resonance-incompatibility,

• Abnormal clinical chemistry,

• Use of drugs that significantly effects energy metabolism,

• Heavy exercise,

• Pregnancy or lactation,

• Allergy of gluten, egg or milk protein

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Weight Gain

Intervention

Other:
• Polyunsaturated fatty acid group
Addition of polyunsaturated fatty acids to the diet in the form of pastries
• Saturated fatty acid group
Addition of saturated fatty acids to the diet in the form of pastries

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, Uppsala Science Park	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic steatosis by magnetic resonance tomography (MRT)		6 weeks	No
Secondary	high density lipoprotein (HDL)		6 weeks	No
Secondary	low density lipoprotein (LDL)		6 weeks	No
Secondary	Insulin		6 weeks	No
Secondary	Glucose		6 weeks	No
Secondary	Triglycerides		6 weeks	No
Secondary	Cholesterol		6 weeks	No
Secondary	Apolipoprotein B (ApoB)		6 weeks	No
Secondary	Apolipoprotein A1 (ApoA1)		6 weeks	No
Secondary	Aspartate aminotransferase (ASAT)		6 weeks	No
Secondary	Alanine aminotransferase (ALAT)		6 weeks	No
Secondary	Gamma glutamyl transpeptidase (GGT)		6 weeks	No
Secondary	Homeostasis model of assessment insulin resistance (HOMA-IR)		6 weeks	No
Secondary	C-reactive protein (CRP)		6 weeks	No
Secondary	Proinsulin		6 weeks	No
Secondary	Endostatin		6 weeks	No
Secondary	Pentraxin-3 (PTX-3)		6 weeks	No
Secondary	Endothelin-1 (ET-1)		6 weeks	No
Secondary	E-selectin		6 weeks	No
Secondary	Cathepsin-S		6 weeks	No
Secondary	Cystatin C		6 weeks	No