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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213559
Other study ID # 26.14-2-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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