Clinical trial NCT01427140: Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)
Official title: Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Liver fat
Polyunsaturated fatty acids (PUFA)
Saturated fatty acids (SFA)
Weight gain
Overfeed
Dietary fatty acids
Palm oil
Sunflower oil
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Hepatic steatosis by magnetic resonance tomography (MRT)
timeFrame: 6 weeks
Secondary outcomes:
measure: high density lipoprotein (HDL)
timeFrame: 6 weeks
measure: low density lipoprotein (LDL)
timeFrame: 6 weeks
measure: Insulin
timeFrame: 6 weeks
measure: Glucose
timeFrame: 6 weeks
measure: Triglycerides
timeFrame: 6 weeks
measure: Cholesterol
timeFrame: 6 weeks
measure: Apolipoprotein B (ApoB)
timeFrame: 6 weeks
measure: Apolipoprotein A1 (ApoA1)
timeFrame: 6 weeks
measure: Aspartate aminotransferase (ASAT)
timeFrame: 6 weeks
measure: Alanine aminotransferase (ALAT)
timeFrame: 6 weeks
measure: Gamma glutamyl transpeptidase (GGT)
timeFrame: 6 weeks
measure: Homeostasis model of assessment insulin resistance (HOMA-IR)
timeFrame: 6 weeks
measure: C-reactive protein (CRP)
timeFrame: 6 weeks
measure: Proinsulin
timeFrame: 6 weeks
measure: Endostatin
timeFrame: 6 weeks
measure: Pentraxin-3 (PTX-3)
timeFrame: 6 weeks
measure: Endothelin-1 (ET-1)
timeFrame: 6 weeks
measure: E-selectin
timeFrame: 6 weeks
measure: Cathepsin-S
timeFrame: 6 weeks
measure: Cystatin C
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Uppsala Science Park
Study officials:
affiliation: Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
name: Ulf Risérus, Ass. professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.
citation: Perfilyev A, Dahlman I, Gillberg L, Rosqvist F, Iggman D, Volkov P, Nilsson E, Riserus U, Ling C. Impact of polyunsaturated and saturated fat overfeeding on the DNA-methylation pattern in human adipose tissue: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):991-1000. doi: 10.3945/ajcn.116.143164. Epub 2017 Mar 8.
citation: Iggman D, Rosqvist F, Larsson A, Arnlov J, Beckman L, Rudling M, Riserus U. Role of dietary fats in modulating cardiometabolic risk during moderate weight gain: a randomized double-blind overfeeding trial (LIPOGAIN study). J Am Heart Assoc. 2014 Oct 15;3(5):e001095. doi: 10.1161/JAHA.114.001095.