Weight Loss Clinical Trial
Official title:
Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
NCT number | NCT04425109 |
Other study ID # | SOY |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | August 31, 2018 |
Verified date | June 2020 |
Source | Universitas Diponegoro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | August 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 21 Years |
Eligibility |
Inclusion Criteria: - BMI > 25 kg/m2 - female Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Etika Ratna Noer | Semarang | Central Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Diponegoro |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change acylated ghrelin | Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake | 1 days | |
Primary | change glucose | Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake | 1 days | |
Primary | change arginine | Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake | 1 days | |
Primary | change insulin | Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake | 1 days | |
Primary | 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 |
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