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Completed

NCT Number: NCT04176614

Cereal-based Products Fortified With Legumes and Effects on Body Weight Management

Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

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

Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. The effects of dietary intervention on body weight reduction will be examined.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • normal exercise and dietary habits
  • weight stable for at least 3 months before enrollment

Exclusion criteria

  • diabetes
  • pregnancy
  • chronic medical illness
  • use of nutritional supplements
  • regular intense exercise
  • alcohol consumption > 2 drinks/day

Treatment and study plan

cereal-legume snack

Other

cereal-legume biscuit

cereal snack

Other

cereal biscuit

Primary outcomes

  1. Change in body weight

    Time frame: 12 weeks

    Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Feb 14, 2022

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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