Back to resultsThe Effect of Mild Weight Loss on Circulating Metabolite Profiles
Primary Purpose
Visceral Fat, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Control group
LCD group
Sponsored by
About this trial
This is an interventional basic science trial for Visceral Fat focused on measuring High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines
Eligibility Criteria
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
Sites / Locations
- Yonsei University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
LCD group
Arm Description
Usual dietary intake group
Low calorie diet (LCD) group (300kcal/day intake reduction)
Outcomes
Primary Outcome Measures
Visceral fat area at L4 (CT)
Visceral fat area at L4 (CT)
Change in visceral fat area at L4 from baseline
Putatively identified plasma metabolites (Normalized peak intensities)
Putatively identified plasma metabolites (Normalized peak intensities)
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03135132
Brief Title
The Effect of Mild Weight Loss on Circulating Metabolite Profiles
Official Title
Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Fat, Weight Loss
Keywords
High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Usual dietary intake group
Arm Title
LCD group
Arm Type
Experimental
Arm Description
Low calorie diet (LCD) group (300kcal/day intake reduction)
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Recommend to consume usual diet during 12-week study period
Intervention Type
Behavioral
Intervention Name(s)
LCD group
Intervention Description
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
Primary Outcome Measure Information:
Title
Visceral fat area at L4 (CT)
Time Frame
At baseline
Title
Visceral fat area at L4 (CT)
Time Frame
At 12-week follow-up
Title
Change in visceral fat area at L4 from baseline
Time Frame
At baseline and 12-week follow-up
Title
Putatively identified plasma metabolites (Normalized peak intensities)
Time Frame
At baseline
Title
Putatively identified plasma metabolites (Normalized peak intensities)
Time Frame
At 12-week follow-up
Title
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
Time Frame
At baseline and 12-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, PhD
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34099056
Citation
Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.
Results Reference
derived
PubMed Identifier
30322392
Citation
Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.
Results Reference
derived
Learn more about this trial
The Effect of Mild Weight Loss on Circulating Metabolite Profiles
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