Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

Study Overview
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Brief Summary
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The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.

Official Title
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Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2 Exclusion Criteria: Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snack bar 1<br>Dietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|
| Experimental: Snack bar 2<br>Dietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|
| Experimental: Snack bar 3<br>Dietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|
| Experimental: Control 1<br>Dietary intervention: Water (500 g) | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|
| Experimental: Control 2<br>Dietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein) | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|
| Experimental: Control 3<br>Dietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein) | Other: Dietary intervention<br>* All arms are given to all participants, in a randomized order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived satiety | Satiety scores (mm) are assessed using 100-mm Motivation to Eat visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the Motivation to Eat visual analog scale is calculated to obtain the average appetite score for statistical analysis | 120 minutes | 
| Blood glucose | Blood glucose (mmol/L) is measured using finger prick capillary blood samples | 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments | 
| Blood insulin | Blood insulin (μU/mL) is measured using finger prick capillary blood samples | 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satiety, Food intake, Breakfast cereals/snacks, Postprandial glycemia