Low-Calorie Diet, Diet, High-Protein, Obesity; Pituitary, Weight Cycling
Conditions
Keywords
Low-Calorie Diet, Diet, High-Protein, Obesity, weight cycling, body composition, high-sensitivity C-Reactive protein, malondialdehyde, glutathione
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
Interventions
BEHAVIORALdiet 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| days of compliance | eight weeks | the number of day in which a participant adhere to the assigned dietary plan |
Countries
Indonesia
Outcome results
None listed