Stearoyl-CoA Desaturase and Energy Metabolism in Humans

Healthy Clinical Trial

— SEM  

Official title:

Stearoyl-CoA Desaturase and Energy Metabolism in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647970
• Other study ID #: 239948-A
• Secondary ID: 2015/634
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2016

Study information

• Verified date: September 2018
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Obesity

Intervention

Behavioral:
• PUFA?Cys/Met diet
Provision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met).
• SFA+Cys/Met diet
Provision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met).

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	The Research Council of Norway, University of Oxford

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic biomarkers	Measurement of biomarkers of amino acid and fatty acid metabolism, including plasma concentration of cysteine, methionine, fatty acids, and stearoyl CoA desaturase (SCD) indices	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	Change in biomarkers of glucose metabolism	Measurements of blood parameters including glucose and insulin, and Oral Glucose Tolerance Test	Baseline and up to 7 days
Secondary	Change in biomarkers of triglycerides metabolism	Measurements of blood parameters including LDL-/HDL-/VLDL-/total cholesterol, and triglycerides	Baseline and up to 7 days
Secondary	Change in molecular signatures	Evaluation of markers related to lipid, amino acid and glucose metabolism, including measurements of mRNA expression in blood cells, and proteins and metabolites, in blood and/or urine	Baseline and up to 7 days
Secondary	Hunger and satiety patterns	Evaluated by plasma levels of hormones such as leptin, ghrelin, cholecystokinin, GLP-1 and PYY	Baseline and up to 7 days
Secondary	Appetite assessed by visual analogue scales		0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially (single meal intervention). Change from baseline up to 7 days (7 days intervention)
Secondary	Change in inflammatory markers	Measurements of blood parameters, e.g., CRP, cytokines and chemokines, adipokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and other important circulating proteins.	Baseline and up to 7 days
Secondary	Feasibility and compliance of the diet intervention	Evaluated by compliance questionnaires	Up to 7 days
Secondary	Tolerance of the diet intervention	Assessed by blood pressure, pulse and laboratory parameters including haematology, clinical chemistry and urine analysis	Up to 7 days