The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling
Primary Purpose
Low-Calorie Diet, Diet, High-Protein, Obesity; Pituitary
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
diet counseling
Sponsored by
About this trial
This is an interventional treatment trial for Low-Calorie Diet focused on measuring Low-Calorie Diet, Diet, High-Protein, Obesity, weight cycling, body composition, high-sensitivity C-Reactive protein, malondialdehyde, glutathione
Eligibility Criteria
Inclusion Criteria:
- body mass index ranging from 25 - 35 kg/m2
- history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years
Exclusion Criteria:
- diabetes mellitus
- history of gastrointestinal tract resection
- hormonal disorders
- using hormonal contraception
- menopause,
- kidney function disruption
Sites / Locations
- Civil Workers' Health Service Center of Special Capital Region
- Seruni Nutrition Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high protein
standard protein
Arm Description
High protein (HP) group were given counseling about weight loss program by applying low calorie-high protein diet with diet menu composition of 22-30% protein, along with instructions for allowed cooking method.
Active comparator receiving standard protein (SP) proportion were counseled about weight loss program by means of low calorie-balanced composition diet with menu comprised of 12-20% protein.
Outcomes
Primary Outcome Measures
body weight
body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
body mass index
a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram per meter squared (kg/m^2) unit
fat mass
actual weight of fat in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
fat mass percentage
the proportion of fat to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed as percentage (%)
muscle mass
The predicted weight of muscle in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
muscle mass percentage
The predicted proportion of muscle weight to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Inflammation marker (high-sensitivity C-reactive protein)
indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device
plasma malondialdehyde level
the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit
plasma gluthatione level
the concentration of glutathione ((2S)-2-Amino-4-{[(1R)-1-[(carboxymethyl)carbamoyl]-2-sulfanylethyl]carbamoyl}butanoic acid) as an endogenous antioxidant compound in the plasma measured by means of Ellman's method expressed in µg/ml plasma unit
Secondary Outcome Measures
days of compliance
the number of day in which a participant adhere to the assigned dietary plan
mean caloric intake
the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie
mean percentage of caloric intake from protein
the average proportion of calories obtained from protein compared to the overall daily caloric intake expressed as percentage (%)
Full Information
NCT ID
NCT03374150
First Posted
December 3, 2017
Last Updated
December 11, 2017
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT03374150
Brief Title
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling
Official Title
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition (Weight, Body Mass Index, Fat Mass (kg), Fat Mass Percentage, Muscle Mass (kg), Muscle Mass Percentage, Inflammation Marker (High-sensitivity C-reactive Protein), and Oxidative Stress Marker (Malondialdehyde and Glutathione) in Obese People With Weight Cycling in Jakarta
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
December 14, 2017 (Anticipated)
Study Completion Date
December 14, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). Studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. The purpose of this research was to evaluate the body composition changes, Inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling.
This is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly counselling
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Calorie Diet, Diet, High-Protein, Obesity; Pituitary, Weight Cycling
Keywords
Low-Calorie Diet, Diet, High-Protein, Obesity, weight cycling, body composition, high-sensitivity C-Reactive protein, malondialdehyde, glutathione
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high protein
Arm Type
Experimental
Arm Description
High protein (HP) group were given counseling about weight loss program by applying low calorie-high protein diet with diet menu composition of 22-30% protein, along with instructions for allowed cooking method.
Arm Title
standard protein
Arm Type
Active Comparator
Arm Description
Active comparator receiving standard protein (SP) proportion were counseled about weight loss program by means of low calorie-balanced composition diet with menu comprised of 12-20% protein.
Intervention Type
Behavioral
Intervention Name(s)
diet counseling
Intervention Description
Subjects were given nutrition consultation, diet recipes, and logbook. Counseling was performed once weekly. During 8 weeks of diet program, subjects were instructed to reduce their daily caloric intake by 500 - 1000 kcal from their previous usual daily intake with limitation in low calorie diet range (800-1500 kcal.day) of calorie intake.Follow-up for each subject was performed once daily by person-to-person encounter. Besides, subjects were contacted by everyday cellphone texting and telephone twice a week to control subject's compliance. After 8 weeks of intervention, subjects were invited to revisit the clinic for anthropometry and body composition measurement after completing the program.
Primary Outcome Measure Information:
Title
body weight
Description
body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Time Frame
eight weeks
Title
body mass index
Description
a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram per meter squared (kg/m^2) unit
Time Frame
eight weeks
Title
fat mass
Description
actual weight of fat in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Time Frame
eight weeks
Title
fat mass percentage
Description
the proportion of fat to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed as percentage (%)
Time Frame
eight weeks
Title
muscle mass
Description
The predicted weight of muscle in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Time Frame
eight weeks
Title
muscle mass percentage
Description
The predicted proportion of muscle weight to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Time Frame
eight weeks
Title
Inflammation marker (high-sensitivity C-reactive protein)
Description
indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device
Time Frame
eight weeks
Title
plasma malondialdehyde level
Description
the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit
Time Frame
eight weeks
Title
plasma gluthatione level
Description
the concentration of glutathione ((2S)-2-Amino-4-{[(1R)-1-[(carboxymethyl)carbamoyl]-2-sulfanylethyl]carbamoyl}butanoic acid) as an endogenous antioxidant compound in the plasma measured by means of Ellman's method expressed in µg/ml plasma unit
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
days of compliance
Description
the number of day in which a participant adhere to the assigned dietary plan
Time Frame
eight weeks
Title
mean caloric intake
Description
the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie
Time Frame
eight weeks
Title
mean percentage of caloric intake from protein
Description
the average proportion of calories obtained from protein compared to the overall daily caloric intake expressed as percentage (%)
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
body mass index ranging from 25 - 35 kg/m2
history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years
Exclusion Criteria:
diabetes mellitus
history of gastrointestinal tract resection
hormonal disorders
using hormonal contraception
menopause,
kidney function disruption
Facility Information:
Facility Name
Civil Workers' Health Service Center of Special Capital Region
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10110
Country
Indonesia
Facility Name
Seruni Nutrition Clinic
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30241565
Citation
Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. doi: 10.1186/s13104-018-3781-z.
Results Reference
derived
Learn more about this trial
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling
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