Clinical trial NCT02647970: Stearoyl-CoA Desaturase and Energy Metabolism in Humans
Official title: Stearoyl-CoA Desaturase and Energy Metabolism in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obesity
Keywords: Energy metabolism
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Oxford
First posted: 2016-01-06
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1) activity through dietary interventions can increase energy metabolism in humans.

Detailed description: In rodents as well as humans, high stearoyl-coenzyme A desaturase-1 (SCD1) activity is considered to be involved in development of obesity. In animal models, polyunsaturated fatty acids (PUFA) inhibit Scd1 gene expression and at the population level, dietary PUFA and plasma PUFA show strong inverse associations with plasma SCD indices. Emerging evidence also suggests a role for the sulphur amino acid cysteine in regulating SCD1 activity and obesity.

The overall aim of the project is to examine if interventions that lowers SCD1 activity lead to increased energy metabolism. In this project, the investigators will conduct dietary intervention trials to evaluate the effects of short-term consumption of a diet rich in polyunsaturated fatty acids (PUFA) and low in cysteine and its precursor methionine (PUFA-Cys/Met) vs. a diet rich in saturated fatty acids (SFA) and cysteine/methionine (SFA+Cys/Met) on SCD1 activity, lipids, amino acids, glucose and other biomarkers related to energy metabolism, in healthy normal-weight subjects. Healthy volunteers will be randomized to the PUFA-Cys/Met or SFA+Cys/Met diets receiving supplements/meals in a single dose or for 7 days.

This study is a pilot study, with main focus on feasibility, tolerance and side effects. If the pilot shows positive results in terms of side effects, safety and tolerance, the investigators will follow-up by including obese subjects in a longer dietary intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy normal-weight (BMI 20-25 kg/m2)

Exclusion Criteria

* High physical activity
* Smoking
* High intake of fatty fish or cod liver oil
* Drugs
* Pregnancy or breastfeeding
* Chronic disease

Primary outcomes:
measure: Change in metabolic biomarkers
timeFrame: 0 hour and at 30 min, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after single meal. Baseline and up to 7 days in 7 days intervention
Secondary outcomes:
measure: Change in biomarkers of glucose metabolism
timeFrame: Baseline and up to 7 days
measure: Change in biomarkers of triglycerides metabolism
timeFrame: Baseline and up to 7 days
measure: Change in molecular signatures
timeFrame: Baseline and up to 7 days
measure: Hunger and satiety patterns
timeFrame: Baseline and up to 7 days
measure: Appetite assessed by visual analogue scales
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)
measure: Change in inflammatory markers
timeFrame: Baseline and up to 7 days
measure: Feasibility and compliance of the diet intervention
timeFrame: Up to 7 days
measure: Tolerance of the diet intervention
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References:
citation: Olsen T, Ovrebo B, Turner C, Bastani NE, Refsum H, Vinknes KJ. Effects of short-term methionine and cysteine restriction and enrichment with polyunsaturated fatty acids on oral glucose tolerance, plasma amino acids, fatty acids, lactate and pyruvate: results from a pilot study. BMC Res Notes. 2021 Feb 2;14(1):43. doi: 10.1186/s13104-021-05463-5.
citation: Olsen T, Turner C, Ovrebo B, Bastani NE, Refsum H, Vinknes KJ. Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study. BMC Res Notes. 2020 Aug 10;13(1):379. doi: 10.1186/s13104-020-05222-y.