Clinical trial NCT04417504: Metabolic and Prolonged Satiety Effects of a Breakfast Kit
Official title: Metabolic and Prolonged Satiety Effects of a Breakfast Kit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet Habit
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: NOVA Medical School
First posted: 2020-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 23
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Secondary outcomes:
measure: Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
measure: Differences in subjective feelings of hunger/satiety between the 2 arms
timeFrame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: NOVA Medical School, NOVA University of Lisbon
Study officials:
References: