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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

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ClinicalTrials.gov Identifier: NCT03374150
Recruitment Status : Active, not recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Fiastuti Witjaksono, Indonesia University

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


Condition or disease Intervention/treatment Phase
Low-Calorie Diet Diet, High-Protein Obesity; Pituitary Weight Cycling Behavioral: diet counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : December 14, 2017
Estimated Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: high protein
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
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.

Active Comparator: standard protein
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.




Primary Outcome Measures :
  1. body weight [ Time Frame: eight weeks ]
    body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit

  2. body mass index [ Time Frame: 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

  3. fat mass [ Time Frame: 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

  4. fat mass percentage [ Time Frame: 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 (%)

  5. muscle mass [ Time Frame: 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

  6. muscle mass percentage [ Time Frame: 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

  7. Inflammation marker (high-sensitivity C-reactive protein) [ Time Frame: eight weeks ]
    indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device

  8. plasma malondialdehyde level [ Time Frame: 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

  9. plasma gluthatione level [ Time Frame: 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


Secondary Outcome Measures :
  1. days of compliance [ Time Frame: eight weeks ]
    the number of day in which a participant adhere to the assigned dietary plan

  2. mean caloric intake [ Time Frame: 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

  3. mean percentage of caloric intake from protein [ Time Frame: eight weeks ]
    the average proportion of calories obtained from protein compared to the overall daily caloric intake expressed as percentage (%)



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374150


Locations
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Indonesia
Civil Workers' Health Service Center of Special Capital Region
Jakarta Pusat, DKI Jakarta, Indonesia, 10110
Seruni Nutrition Clinic
Jakarta, Jakarta Pusat, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fiastuti Witjaksono, Principal Invdstigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03374150     History of Changes
Other Study ID Numbers: PITTAgizi
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fiastuti Witjaksono, Indonesia University:
Low-Calorie Diet
Diet, High-Protein
Obesity
weight cycling
body composition
high-sensitivity C-Reactive protein
malondialdehyde
glutathione

Additional relevant MeSH terms:
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Body Weight
Inflammation
Signs and Symptoms
Pathologic Processes