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

NCT ID: NCT03374150

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-26
• Study Completion Date: 2017-12-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

diet counseling

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

diet counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Fiastuti Witjaksono

Principal Invdstigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Civil Workers' Health Service Center of Special Capital Region

Jakarta Pusat, DKI Jakarta, Indonesia

Seruni Nutrition Clinic

Jakarta, Jakarta Pusat, Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 30241565 (View on PubMed)

Other Identifiers

PITTAgizi

Identifier Type: -

Identifier Source: org_study_id