The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood

NCT ID: NCT02471092

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia Lack of Satiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

satiety glycemia milk protein

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Water Control

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

Group Type PLACEBO_COMPARATOR

Skim milk products

Intervention Type OTHER

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

Skim Milk

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

Group Type ACTIVE_COMPARATOR

Skim milk products

Intervention Type OTHER

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

High Protein Milk

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

Group Type EXPERIMENTAL

Skim milk products

Intervention Type OTHER

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

High Protein Milk (Modified Ratio)

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

Group Type EXPERIMENTAL

Skim milk products

Intervention Type OTHER

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

Skim Milk (Modified Ratio)

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

Group Type EXPERIMENTAL

Skim milk products

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Skim milk products

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toronto

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amanda Wright, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda J Wright, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Guelph- Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33024990 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14JN004

Identifier Type: -

Identifier Source: org_study_id