Weight Cycling Clinical Trial
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
| Verified date | December 2017 |
| Source | Indonesia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 54 |
| Est. completion date | December 14, 2017 |
| Est. primary completion date | December 14, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Seruni Nutrition Clinic | Jakarta | Jakarta Pusat |
| Indonesia | Civil Workers' Health Service Center of Special Capital Region | Jakarta Pusat | DKI Jakarta |
| Lead Sponsor | Collaborator |
|---|---|
| Indonesia University |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | body weight | body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit | eight weeks | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Inflammation marker (high-sensitivity C-reactive protein) | indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device | eight weeks | |
| Primary | 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 | |
| Primary | 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 | days of compliance | the number of day in which a participant adhere to the assigned dietary plan | eight weeks | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05311462 -
An Observational Cohort Study to Obese Patients With Weight Cycling
|