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Completed

NCT Number: NCT01427140

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

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.

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Key information

Conditions

Healthy Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Liver Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

20 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Uppsala Science Park

Uppsala, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyunsaturated fatty acid group

Other

Addition of polyunsaturated fatty acids to the diet in the form of pastries

Saturated fatty acid group

Other

Addition of saturated fatty acids to the diet in the form of pastries

Primary outcomes

  1. Hepatic steatosis by magnetic resonance tomography (MRT)

    Time frame: 6 weeks

Secondary outcomes

  1. high density lipoprotein (HDL)

    Time frame: 6 weeks

  2. low density lipoprotein (LDL)

    Time frame: 6 weeks

  3. Insulin

    Time frame: 6 weeks

  4. Glucose

    Time frame: 6 weeks

  5. Triglycerides

    Time frame: 6 weeks

  6. Cholesterol

    Time frame: 6 weeks

  7. Apolipoprotein B (ApoB)

    Time frame: 6 weeks

  8. Apolipoprotein A1 (ApoA1)

    Time frame: 6 weeks

  9. Aspartate aminotransferase (ASAT)

    Time frame: 6 weeks

  10. Alanine aminotransferase (ALAT)

    Time frame: 6 weeks

  11. Gamma glutamyl transpeptidase (GGT)

    Time frame: 6 weeks

  12. Homeostasis model of assessment insulin resistance (HOMA-IR)

    Time frame: 6 weeks

  13. C-reactive protein (CRP)

    Time frame: 6 weeks

  14. Proinsulin

    Time frame: 6 weeks

  15. Endostatin

    Time frame: 6 weeks

  16. Pentraxin-3 (PTX-3)

    Time frame: 6 weeks

  17. Endothelin-1 (ET-1)

    Time frame: 6 weeks

  18. E-selectin

    Time frame: 6 weeks

  19. Cathepsin-S

    Time frame: 6 weeks

  20. Cystatin C

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: LIPOGAIN

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2011
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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