Clinical trial NCT03374150: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: body weight
timeFrame: eight weeks
measure: body mass index
timeFrame: eight weeks
measure: fat mass
timeFrame: eight weeks
measure: fat mass percentage
timeFrame: eight weeks
measure: muscle mass
timeFrame: eight weeks
measure: muscle mass percentage
timeFrame: eight weeks
measure: Inflammation marker (high-sensitivity C-reactive protein)
timeFrame: eight weeks
measure: plasma malondialdehyde level
timeFrame: eight weeks
measure: plasma gluthatione level
timeFrame: eight weeks
Secondary outcomes:
measure: days of compliance
timeFrame: eight weeks
measure: mean caloric intake
timeFrame: eight weeks
measure: mean percentage of caloric intake from protein
timeFrame: eight weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Civil Workers' Health Service Center of Special Capital Region
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Seruni Nutrition Clinic
state: Jakarta Pusat
Study officials:
References:
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.