Clinical trial NCT02471092: The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Official title: The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Lack of Satiety
Keywords: satiety
glycemia
milk protein
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Laval University
First posted: 2015-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.

Detailed description: 1. A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
2. Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.

Eligibility criteria: Inclusion Criteria:

* BMI 20 - 24.9 kg/m2
* Healthy as determined by screening questionnaire
* Male or Female
* Non-smoking
* Normal fasting plasma glucose (\<5.5 mmol/L), but not below 3.3 mmol/L.
* Prior use of acetaminophen

Exclusion Criteria:

* Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
* Weight loss or weight gain of more than 5 kg during the previous 2 months
* Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
* Serious medical condition (ie. Renal, liver)
* Lack of appetite or skipping breakfast
* Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint \>16
* Smoking
* Reported intolerance to milk or very low consumption (\< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.
* Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise
* Diabetes or other metabolic diseases that could interfere with study outcomes
* Acetaminophen, codeine or opioid allergy
* Pregnant or Breast Feeding
* Typical alcohol consumption of not more than 4 drinks per sitting

Primary outcomes:
measure: Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
timeFrame: 0-200 minutes
Secondary outcomes:
measure: Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)
timeFrame: 0-200 minutes
measure: Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)
timeFrame: at 120 minutes
Other outcomes:
measure: Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)
timeFrame: 0-200 minutes
Locations:
city: Guelph
country: Canada
facility: University of Guelph- Human Nutraceutical Research Unit
state: Ontario
Study officials:
affiliation: University of Guelph
name: Amanda J Wright, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kung B, Turgeon SL, Vien S, Kubant R, El Khoury D, Wright AJ, Goff HD, Anderson GH. Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio. J Nutr. 2020 Dec 10;150(12):3103-3113. doi: 10.1093/jn/nxaa275.