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

NCT03374150 | Unknown

• 1 other identifier: PITTAgizi
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Conditions

Low-Calorie Diet; Diet, High-Protein; Obesity; Pituitary; Weight Cycling

Keywords

Low-Calorie Diet; Diet, High-Protein; Obesity; weight cycling; body composition; high-sensitivity C-Reactive protein; malondialdehyde; glutathione

Outcome Measures

Primary Outcomes (9)

• body weight

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

  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

  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

  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 (%)

  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

  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

  eight weeks

• Inflammation marker (high-sensitivity C-reactive protein)

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

  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

  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

  eight weeks

Secondary Outcomes (3)

• days of compliance

  eight weeks

• mean caloric intake

  eight weeks

• mean percentage of caloric intake from protein

  eight weeks

Study Arms (2)

high protein

EXPERIMENTAL

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

standard protein

ACTIVE COMPARATOR

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

Interventions

diet counseling BEHAVIORAL

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.

high protein; standard protein

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Civil Workers' Health Service Center of Special Capital Region

Jakarta Pusat, DKI Jakarta, 10110, Indonesia

Location

Seruni Nutrition Clinic

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 30241565 DERIVED

MeSH Terms

Conditions

Obesity; Pituitary Diseases; Weight Cycling

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes; Weight Loss

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invdstigator

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 15, 2017
• Study Start: May 26, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)