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OpenTrials
Completed

NCT Number: NCT05213559

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

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.

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Key information

Conditions

Appetite

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, Attica, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wheat biscuit enriched with plant proteins

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

common wheat biscuit

Other

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

Primary outcomes

  1. change in postprandial glucose response

    Time frame: 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 outcomes

  1. change in postprandial appetite regulating hormone responses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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