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

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

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

Study Overview

• Status: Unknown
• Conditions: Low-Calorie Diet; Diet, High-Protein; Obesity; Pituitary; Weight Cycling
• Intervention / Treatment: Behavioral: diet counseling

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10110
      • Civil Workers' Health Service Center of Special Capital Region
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10430
      • Seruni Nutrition Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high protein; 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; 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.
Active Comparator: standard protein; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2017
• Primary Completion (Anticipated): December 14, 2017
• Study Completion (Anticipated): December 14, 2017

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; body composition; glutathione; malondialdehyde; weight cycling; Diet, High-Protein; Low-Calorie Diet; high-sensitivity C-Reactive protein
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Body Weight
• Other Study ID Numbers: PITTAgizi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No