Metabolic and Prolonged Satiety Effects of a Breakfast Kit

Diet Habit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04417504
• Other study ID #: MobFood
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2019
• Source: Universidade do Porto
• Contact: Conceição Calhau, PhD
• Phone: 00351 218803035
• Email: ccalhau[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit

Intervention

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.
• Control isocaloric breakfast
White bread, butter and milk.

Locations

Country	Name	City	State
Portugal	NOVA Medical School, NOVA University of Lisbon	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research, NOVA Medical School

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)