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

NCT ID: NCT05213559

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appetite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

wheat biscuit enriched with plant proteins

Intervention Type OTHER

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

wheat biscuit

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

Group Type ACTIVE_COMPARATOR

common wheat biscuit

Intervention Type OTHER

Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Amalia Yanni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Kokkinos, Professor

Role: STUDY_CHAIR

National and Kapodistrian University of Athens

Amalia Yanni, PhD

Role: PRINCIPAL_INVESTIGATOR

Harokopio University

Locations

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Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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26.14-2-2020

Identifier Type: -

Identifier Source: org_study_id

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