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Low-Calorie DietNCT03374150

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

A study testing diet counseling in people with Low-Calorie Diet and Diet, High-Protein, run by Universitas Indonesia at 2 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
What is being tested?
diet counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesIndonesia
Study dates
26 May 2017to 14 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • diabetes mellitus
  • history of gastrointestinal tract resection
  • hormonal disorders
  • using hormonal contraception
  • menopause,
  • kidney function disruption

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Seruni Nutrition Clinic

    Jakarta, Jakarta Pusat, 10430

  • Civil Workers' Health Service Center of Special Capital Region

    Jakarta Pusat, DKI Jakarta, 10110

Other trials in Indonesia

About this study

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

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

Being tested
diet counseling
Keywords
Low-Calorie Diet, Diet, High-Protein, Obesity, weight cycling, body composition, high-sensitivity C-Reactive protein, malondialdehyde, glutathione
Medical subject headings
Obesity, Pituitary Diseases, Weight Cycling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diet counselingBehavioural

    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.

Study groups in NCT03374150
Study groupRoleWhat they receive
high proteinExperimentalHigh 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.
Receives: Behavioral: diet counseling
standard proteinActive comparatorActive 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.
Receives: Behavioral: diet counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit

    Measured: eight weeks

  2. 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

    Measured: eight weeks

  3. 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

    Measured: eight weeks

  4. 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 (%)

    Measured: eight weeks

  5. 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

    Measured: eight weeks

  6. 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

    Measured: eight weeks

  7. Inflammation marker (high-sensitivity C-reactive protein)

    indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device

    Measured: eight weeks

  8. 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

    Measured: eight weeks

  9. 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

    Measured: eight weeks

Secondary outcomes (3)

  1. days of compliance

    the number of day in which a participant adhere to the assigned dietary plan

    Measured: eight weeks

  2. 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

    Measured: eight weeks

  3. 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 (%)

    Measured: eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start26 May 2017
  3. Primary completion14 Dec 2017 (estimated)
  4. Study completion14 Dec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03374150
Sponsor's protocol ID
PITTAgizi
Status last verified
Dec 2017
First submitted
3 Dec 2017
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30241565

Questions about this trial

What is this clinical trial studying?

A study testing diet counseling in people with Low-Calorie Diet and Diet, High-Protein, run by Universitas Indonesia at 2 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight (time frame: eight weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03374150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.

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