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

NCT05213559 | Completed DMC

• 1 other identifier: 26.14-2-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite

Keywords

cereal-based biscuit enriched with plant proteins; appetite regulation; glycemic control; hormone responses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in postprandial appetite regulating hormone responses

  Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.

Study Arms (2)

wheat-based biscuit enriched with plant proteins

EXPERIMENTAL

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

wheat biscuit

ACTIVE COMPARATOR

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

Other: common wheat biscuit

Interventions

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

wheat-based 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

wheat biscuit

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Eligibility is based on gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-diabetic women with overweight/obesity
• constant body weight for the last three months before enrollment
• standard dietary and physical activity habits

You may not qualify if:

• pregnancy
• lactation
• chronic medical illness
• use of nutritional supplements
• alcohol consumption \>2 drinks per day

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

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

Athens, Attica, 11527, Greece

Location

MeSH Terms

Interventions

Plant Proteins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Alexander Kokkinos, Professor

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Amalia Yanni, PhD

  Harokopio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)