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

Sponsor

Harokopio University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05213559

Collaborator

National and Kapodistrian University of Athens (Other)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Appetite	Other: wheat biscuit enriched with plant proteins Other: common wheat biscuit	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: wheat-based biscuit enriched with plant proteins Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily.	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
Active Comparator: wheat biscuit Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily.	Other: 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

Arm

Intervention/Treatment

Experimental: wheat-based biscuit enriched with plant proteins

Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily.

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

Active Comparator: wheat biscuit

Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily.

Other: 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

Outcome Measures

Primary Outcome Measures

change in postprandial glucose response [Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.]
change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.

Secondary Outcome Measures

change in postprandial appetite regulating hormone responses [Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.]
changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens	Athens	Attiki	Greece	11527

Sponsors and Collaborators

Harokopio University
National and Kapodistrian University of Athens

Investigators

Study Chair: Alexander Kokkinos, Professor, National and Kapodistrian University of Athens
Principal Investigator: Amalia Yanni, PhD, Harokopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amalia Yanni, Principal Investigator, Harokopio University

ClinicalTrials.gov Identifier:

NCT05213559

Other Study ID Numbers:

26.14-2-2020

First Posted:

Jan 28, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amalia Yanni, Principal Investigator, Harokopio University

cereal-based biscuit enriched with plant proteins

appetite regulation

glycemic control

hormone responses

Study Results

No Results Posted as of Aug 3, 2022