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

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

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.

Study Overview

• Status: Completed
• Conditions: Appetite
• Intervention / Treatment: Other: wheat biscuit enriched with plant proteins; Other: common wheat biscuit

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: appetite regulation; glycemic control; cereal-based biscuit enriched with plant proteins; hormone responses
• Other Study ID Numbers: 26.14-2-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No