NCT02471092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

May 26, 2015

Last Update Submit

October 24, 2016

Conditions

HyperglycemiaLack of Satiety

Keywords

satietyglycemiamilk protein

Outcome Measures

Primary Outcomes (1)

  • Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)

    0-200 minutes

Secondary Outcomes (2)

  • Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)

    0-200 minutes

  • Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)

    at 120 minutes

Other Outcomes (1)

  • Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)

    0-200 minutes

Study Arms (5)

Water Control

PLACEBO COMPARATOR

Skim milk products. Water and permeate control; 250mL serving.

Other: Skim milk products

Skim Milk

ACTIVE COMPARATOR

Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.

Other: Skim milk products

High Protein Milk

EXPERIMENTAL

Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.

Other: Skim milk products

High Protein Milk (Modified Ratio)

EXPERIMENTAL

Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.

Other: Skim milk products

Skim Milk (Modified Ratio)

EXPERIMENTAL

Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.

Other: Skim milk products

Interventions

Skim milk productsOTHER

Milk treatments will be served with 58g of breakfast cereal.

High Protein MilkHigh Protein Milk (Modified Ratio)Skim MilkSkim Milk (Modified Ratio)Water Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph- Human Nutraceutical Research Unit

Guelph, Ontario, N1G2W1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33024990DERIVED

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Amanda J Wright, Ph.D.

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 15, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

CA(1)