The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity

NCT04425109 | Completed DMC

• 1 other identifier: SOY
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Limited data are available regarding the satiety effects from fermented and non-fermented soy-based food. The aim of this study was to compare fermented (tempeh) and non-fermented soy-based diets high in protein in increasing satiety. Thirteen young obese females were studied in single-blind and cross over design. Blood samples were assessed frequently for 0, 30 and 120 minutes after consumption of two isocaloric breakfast which consist of tempeh and non-fermented soybean content. The energy content was 27% protein, 21% fat and 52% carbohydrate. Subjective satiety score was recorded at 30 and 120 minutes after taking a meal. Compared to non-fermented soybean, tempeh showed a steady trend in postprandial ghrelin, significantly increasing insulin and arginine, and decreasing glucose at 120 minutes. Satiety scores had the same trend in the hunger and fullness aspects between the meals.

Conditions

Obesity, Abdominal; Weight Loss

Keywords

tempeh; appetite; satiety; obesity

Outcome Measures

Primary Outcomes (5)

• change acylated ghrelin

  Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake

  1 days

• change glucose

  Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake

  1 days

• change arginine

  Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake

  1 days

• change insulin

  Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake

  1 days

• Visual Analogue scale (VAS)

  VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)

  1 days

Study Arms (2)

tempeh steak

EXPERIMENTAL

The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal

Behavioral: meal test response

soybean steak

EXPERIMENTAL

The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal

Behavioral: meal test response

Interventions

meal test response BEHAVIORAL

soy fermented versus non fermented meal test

soybean steak; tempeh steak

Eligibility Criteria

• Age: 19 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 25 kg/m2
• female

You may not qualify if:

• clinically significant history of chronic diseases, such as cardiovascular disease, diabetes, dyslipidemia or hypertension
• use of a weight-related medication/food;
• heavy alcohol/drug consumption;
• pregnancy and breastfeeding

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

Location

Related Publications (1)

• Noer ER, Dewi L, Kuo CH. Fermented soybean enhances post-meal response in appetite-regulating hormones among Indonesian girls with obesity. Obes Res Clin Pract. 2021 Jul-Aug;15(4):339-344. doi: 10.1016/j.orcp.2021.06.005. Epub 2021 Jun 17.

  PMID: 34147377 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Etika Noer

  Universitas Diponegoro

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nutrition, Medical Faculty

Model Details: Group 1 : give tempeh steak Group 2 : give soybean steak washout 3 days Group 1 : give soybean steak Group 2 : give tempeh steak

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 11, 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)