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

Not Applicable

• Conditions: Diet, High-Protein; Weight Cycling; Low-Calorie Diet; Obesity; Pituitary
• Interventions: Behavioral: diet counseling

• Registration Number: NCT03374150
• Lead Sponsor: Indonesia University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-26
• Status Verified: 2017-12
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Study First Posted: 2017-12-15
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high protein	diet counseling	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.
standard protein	diet counseling	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.

Primary Outcome Measures

Name	Time	Method
body weight	eight weeks	body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
body mass index	eight weeks	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	eight weeks	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	eight weeks	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	eight weeks	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	eight weeks	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)	eight weeks	indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device
plasma malondialdehyde level	eight weeks	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	eight weeks	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

Name	Time	Method
days of compliance	eight weeks	the number of day in which a participant adhere to the assigned dietary plan
mean caloric intake	eight weeks	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	eight weeks	the average proportion of calories obtained from protein compared to the overall daily caloric intake expressed as percentage (%)

Trial Locations

Locations (2)

Civil Workers' Health Service Center of Special Capital Region; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Seruni Nutrition Clinic; 🇮🇩 Jakarta, Jakarta Pusat, Indonesia