Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit

Appetite Clinical Trial

Official title:

Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213559
• Other study ID #: 26.14-2-2020
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

Description:

Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.

At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• non-diabetic women with overweight/obesity

• constant body weight for the last three months before enrollment

• standard dietary and physical activity habits

Exclusion Criteria:

• pregnancy

• lactation

• chronic medical illness

• use of nutritional supplements

• alcohol consumption >2 drinks per day

Related Conditions & MeSH terms

• Appetite

Intervention

Other:
• wheat biscuit enriched with plant proteins
Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins
• common wheat biscuit
Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit

Locations

Country	Name	City	State
Greece	Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in postprandial glucose response	change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.	Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
Secondary	change in postprandial appetite regulating hormone responses	changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning.	Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.