The Effect of Mild Weight Loss on Circulating Metabolite Profiles

Weight Loss Clinical Trial

Official title:

Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135132
• Other study ID #: Wt loss_metabolites
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: April 26, 2017
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Description:

Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Able to give informed consent

• 20-65 years old

• Males and females

• Overweight (25.0 kg/m²= Body mass index <30 kg/m²)

• Nondiabetic (Fasting glucose <126 mg/dL)

Exclusion Criteria:

• Unstable body weight (body weight change >1 kg within 3 months before screening)

• Consumption of medication that affects body weight or energy expenditure

• Pregnancy or breast-feeding

• Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease

• Liver disease, kidney disease, or gastrointestinal disease

• Acute or chronic infections

• Any acute or chronic disease requiring treatment

Related Conditions & MeSH terms

• Body Weight
• Visceral Fat
• Weight Loss

Intervention

Behavioral:
• Control group
Recommend to consume usual diet during 12-week study period
• LCD group
Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral fat area at L4 (CT)		At baseline
Primary	Visceral fat area at L4 (CT)		At 12-week follow-up
Primary	Change in visceral fat area at L4 from baseline		At baseline and 12-week follow-up
Primary	Putatively identified plasma metabolites (Normalized peak intensities)		At baseline
Primary	Putatively identified plasma metabolites (Normalized peak intensities)		At 12-week follow-up
Primary	Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline		At baseline and 12-week follow-up