Metabolic and Prolonged Satiety Effects of a Breakfast Kit

Metabolic and Prolonged Satiety Effects of a Breakfast Kit: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Diet Habit
• Intervention / Treatment: Other: MobFood breakfast kit; Other: Control isocaloric breakfast

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Conceição Calhau, PhD; Phone Number: 20401 00351 218803035; Email: ccalhau@nms.unl.pt

Study Locations

• Portugal
  • Lisbon, Portugal
    • NOVA Medical School, NOVA University of Lisbon
    • Contact: Conceição Calhau, PhD; Phone Number: +351918482491; Email: mobfood@nms.unl.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MobFood breakfast kit	Other: 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.
Experimental: Control isocaloric breakfast	Other: Control isocaloric breakfast; White bread, butter and milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms	The iAUC for TG 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 for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms	The iAUC for NEFA 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 subjective feelings of hunger/satiety between the 2 arms	Difference in subjective feelings of hunger/satiety from fasting state to post-prandial state with the consumption of the test and control products	at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: NOVA Medical School; Center for Health Technology and Services Research

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MobFood

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No