Metabolic and Prolonged Satiety Effects of a Breakfast Kit

NCT ID: NCT04417504

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-10-31

Brief Summary

The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer the current nutrition market challenges - is formed by a consortium of 47 collaborative entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de Investigação e Inovação) and is financed by Structural European Funds of Investment.

The project is currently investigating and undertaking collaborative scientific and technological strategies based on R&D and innovation, in order to boost and promote a more competitive national food industry, capable of overcoming the current challenges, including those of the Millennial Generation. This group is particularly conscious of the impact of food behaviour and food choices on health but extremely vulnerable to dietary imbalance. Strategies to improve Millenials' nutrition while providing conscious food products are needed.

This study is a randomised, cross-over controlled trial designed to test the metabolic effect, particularly in terms of appetite control and glycaemic response of a breakfast kit (nutritionally balanced and innovative), recently developed as part of the collaborative project MobFood_PPS4.

Conditions

Diet Habit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MobFood breakfast kit

Group Type: EXPERIMENTAL

MobFood breakfast kit

Intervention Type: OTHER

Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood\_PPS4.

Control isocaloric breakfast

Group Type: EXPERIMENTAL

Control isocaloric breakfast

Intervention Type: OTHER

White bread, butter and milk.

Interventions

MobFood breakfast kit

Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood\_PPS4.

Intervention Type: OTHER

Control isocaloric breakfast

White bread, butter and milk.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female;
• Born between 1981 and 1996;
• Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;
• Normoglycemic according to American Diabetes Association criteria [Fasting Plasma Glucose < 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance test (OGTT) < 140 mg/dl)];
• Healthy.

Exclusion Criteria

• Overweight or obese (BMI ≥ 25,0 kg/m2);
• Recent body weight loss/gain >10%, within previous 3 months;
• Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian diet or ketogenic diet), within previous 3 months;
• Clinically significant illness, including:

type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease; previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological, psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.

• Individuals who don't regularly consume breakfast;
• Having taken antibiotics within the 12 weeks prior to beginning the study;
• Taking other medication that could potentially affect body weight, glucose metabolism and/or appetite (e.g. GLP-1 analogues);
• Being engaged in competitive sports;
• Having >14 or >8 (males and females, respectively) alcoholic units/week; misuse of drugs;
• Having donated blood within one month prior to the beginning of the study;
• Nut or milk allergy, or other food allergy or intolerance that would compromise compliance with the study protocol;
• Pregnant or breastfeeding.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Health Technology and Services Research

OTHER

Sponsor Role: collaborator

NOVA Medical School

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NOVA Medical School, NOVA University of Lisbon

Lisbon, , Portugal

Countries

Portugal

Central Contacts

Conceição Calhau, PhD

Role: CONTACT

ccalhau@nms.unl.pt

00351 218803035 ext. 20401

Facility Contacts

Conceição Calhau, PhD

Role: primary

mobfood@nms.unl.pt

+351918482491

Other Identifiers

MobFood

Identifier Type: -

Identifier Source: org_study_id