An interventional study of diet counseling in Low-Calorie Diet, Diet, High-Protein and Obesity; Pituitary, sponsored by Indonesia University. Status unknown at 2 sites in Indonesia. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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Among 16 studies in Obesity by Indonesia University — none open to participants now, 2 under way, none of them phase 3. Obesity · Indonesia University.
Among the 16 studies in Obesity by Indonesia University, this one is the 7th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 12 with no phase, and was the 1st registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →None of the 16 studies in Obesity by Indonesia University is open now. The open studies under Obesity, anywhere →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 20 Years to 50 Years · all sexes · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 54 is below the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 54 across the 14 interventional studies, 339 across the 2 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Obesity by Indonesia University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
body weight
body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Time frame: 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
Time frame: 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
Time frame: 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 (%)
Time frame: 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
Time frame: 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
Time frame: eight weeks
Inflammation marker (high-sensitivity C-reactive protein)
indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device
Time frame: 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
Time frame: 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
Time frame: eight weeks
days of compliance
the number of day in which a participant adhere to the assigned dietary plan
Time frame: 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
Time frame: 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 (%)
Time frame: eight weeks
Plan to share: No
Started May 2017 (actual). Primary completion is estimated for Dec 2017, 6 months after the start.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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