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Completed

NCT Number: NCT02465021

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences, University of Toronto

Toronto, Ontario, M5S3E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

All arms are given to all participants, in a randomized order

Primary outcomes

  1. Food intake

    Time frame: 120 minutes

    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

Secondary outcomes

  1. Perceived satiety

    Time frame: 120 minutes

    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

  2. Blood glucose

    Time frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments

    Blood glucose (mmol/L) is measured using finger prick capillary blood samples

  3. Blood insulin

    Time frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments

    Blood insulin (μU/mL) is measured using finger prick capillary blood samples

Other outcomes

  1. Food Recall

    Time frame: 24 hours

    Participants are asked to complete a 24-hour Food Recall starting at dinner the night before each study session and ending at dinner the day of that session.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • General Mills

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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