Metabolic and Prolonged Satiety Effects of a Breakfast Kit

NCT04417504 | Unknown

• 1 other identifier: MobFood
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms

  The iAUC for glucose will be calculated based on the concentration curve following consumption of the test and control products, over 2h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms

  The iAUC for GLP-1 will be calculated based on the concentration curve following consumption of the test and control products, over 3h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms

  The iAUC for PYY will be calculated based on the concentration curve following consumption of the test and control products, over 3h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms

  The iAUC for CKK will be calculated based on the concentration curve following consumption of the test and control products, over 3h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms

  The iAUC for ghrelin will be calculated based on the concentration curve following consumption of test and control products, over 3h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms

  The iAUC for glucagon will be calculated based on the concentration curve following consumption of the test and control products, over 3h

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

Secondary Outcomes (3)

• Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

• Differences in subjective feelings of hunger/satiety between the 2 arms

  at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

Study Arms (2)

MobFood breakfast kit

EXPERIMENTAL

Other: MobFood breakfast kit

Control isocaloric breakfast

EXPERIMENTAL

Other: Control isocaloric breakfast

Interventions

MobFood breakfast kit 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.

MobFood breakfast kit

Control isocaloric breakfast OTHER

White bread, butter and milk.

Control isocaloric breakfast

Eligibility Criteria

• Age: 23 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Center for Health Technology and Services Research: collaborator
• NOVA Medical School: collaborator

Study Sites (1)

NOVA Medical School, NOVA University of Lisbon

Lisbon, Portugal

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Central Study Contacts

Conceição Calhau, PhD

CONTACT

00351 218803035; ccalhau@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: June 9, 2020

Record last verified: 2019-11

Locations

PT (1)