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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Low-Calorie Diet, Diet, High-Protein, Obesity; Pituitary, Weight Cycling

Intervention / Treatment
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* Behavioral: diet counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high protein<br>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. | Behavioral: diet counseling<br>* 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.<br>|
| Active Comparator: standard protein<br>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. | Behavioral: diet counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit | eight weeks | 
| 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 | eight weeks | 
| 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 | eight weeks | 
| 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 (%) | eight weeks | 
| 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 | eight weeks | 
| 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 | eight weeks | 
| Inflammation marker (high-sensitivity C-reactive protein) | indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device | eight weeks | 
| 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 | eight weeks | 
| 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 | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of compliance | the number of day in which a participant adhere to the assigned dietary plan | eight weeks | 
| 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 | eight weeks | 
| 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 (%) | eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-Calorie Diet, Diet, High-Protein, Obesity, weight cycling, body composition, high-sensitivity C-Reactive protein, malondialdehyde, glutathione