The Effect High Protein-Fiber Diet With Exercise on Acylated Ghrelin and Leptin in Obese Adolescents

NCT04377906 | Completed DMC

• 1 other identifier: ERN
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity has been reported to impair regulation of appetite and lead uncontrollably hunger and satiety response. Ghrelin is orexigenic hormone from the stomach meanwhile, leptin is anorexigenic from adipose. Interestingly, obesity is associated with acylated ghrelin and leptin resistance. Study about the impact of high protein and fiber with combined exercise (HPFE) to suppress hunger among young obese still unclear. The hypothesis was that high protein-fiber would result in decreased in acylated ghrelin and leptin in HPFE group. Thus, the investigator examined the effect of an 8 weeks HPFE on acylated ghrelin and leptin. Subjects were randomized into four groups: High Protein-Fiber (HPF; n=15). High Protein-Fiber and exercise (HPFE; n=15), Exercise (E; n=15) and control (C; n=15). The diet prescribed 1200 kcal/day, based on basic energy requirement minus 300kcal, consisted high protein (25%) and fiber (30g/day). The exercise is combination aerobic and resistance training, with target 75% heart rate maximum. Plasma acylated ghrelin and leptin were analyzed with enzyme immunoassay.

Conditions

Weight Loss; Adolescent Obesity

Keywords

high protein-fiber; acylated ghrelin; leptin

Outcome Measures

Primary Outcomes (3)

• change acylated ghrelin

  Change from Baseline acyl ghrelin at 8 weeks taken in the lab from venous blood specimen after10h fasting using ELISA method

  8 weeks

• change leptin

  Change from Baseline leptin at 8 weeks taken in the lab from venous blood specimen after10h fasting using ELISA method

  8 weeks

• change body weight

  change from baseline body weight at 8 weeks measured using bioelectrical impedance analysis (BIA) with light clothes and no shoes

  8 weeks

Secondary Outcomes (2)

• change triglyceride

  8 weeks

• change high density lipoprotein

  8 weeks

Study Arms (4)

High Protein-Fiber and Exercise

EXPERIMENTAL

give 1200 Kcal with 25% protein from fish and tempeh and 30g fiber from vegetable and fruit, 3 times/day and exercise : aerobic and resistance training for 5x/week, 45 minute each sesion

Behavioral: Modification Lifesyle

High Protein-Fiber

EXPERIMENTAL

give 1200 Kcal with 25% protein from fish and tempeh and 30g fiber from vegetable and fruit, 3 times/day

Behavioral: Modification Lifesyle

Exercise

EXPERIMENTAL

aerobic and resistance training for 5x/week, 45 minute each sesion

Behavioral: Modification Lifesyle

control

NO INTERVENTION

regular diet

Interventions

Modification Lifesyle BEHAVIORAL

high protein-fiber and exercise

Exercise; High Protein-Fiber; High Protein-Fiber and Exercise

Eligibility Criteria

• Age: 19 Years - 20 Years
• Gender Eligibility Details: female and male is equal
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index \> 25 kg/m2,
• waist circumference \>80 cm for female and \>90 cm for male

You may not qualify if:

• taking dietary supplements or medication
• smokers
• have pregnancy
• lose body weight \> 10% before treatment
• have chronic disease history

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

Location

MeSH Terms

Conditions

Weight Loss; Pediatric Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Etika Noer

  Diponegoro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: subject with random allocation Investigator do not know the group the analysator do not know the group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nutrition, Medical Faculty

Model Details: four arm parallel group with 56 young obesity: 1. high protein-fiber diet and exercise 2. high protein-fiber diet 3. exercise 4. control

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 7, 2020
• Study Start: June 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 30, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anytime
• Access Criteria: etikaratna@fk.undip.ac.id

Locations

ID (1)