- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151188
Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response
February 1, 2016 updated by: Melvin Leow, Clinical Nutrition Research Centre, Singapore
This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.
Study Overview
Status
Completed
Conditions
Detailed Description
Consumption of milk proteins increase satiety and reduce glucose response when consumed alone or with carbohydrate.
Milk proteins are of interest because proteins are more satiating than either carbohydrate or fat, and they regulate food intake and metabolic functions by the intact protein, encrypted peptides and amino acids on gastrointestinal and central pathways.
White rice and white bread are two common carbohydrates types mostly consumed in Asia.
Both of them are known to result in high glycaemic and insulinaemic responses.
However, in most meals, they are accompanied by other foods such as soy milk, cow milk products.
The glyceamic and insulinaemic responses are determined by the type of protein and the type of carbohydrates.
And also the consumption time of protein and carbohydrate.
Recent research points to an intrinsic value of small amounts of milk protein or dairy consumed shortly before a meal can reduce the glycemic response to carbohydrate and that this is not at the cost of increased demand for insulin.
The objective of the present study is to investigate how glycaemic, insulinaemic and satiety responses to a white rice or white bread meal changed when a soy milk or cow milk consumed together or shortly before the meal.
Whole soy milk and whole cow milk will be added to the meal.
Healthy subjects (n 15) will ingest the test meals once.
The meals will be provided as breakfasts, on 10 different occasions, in random order with ≥ 7 days between each.
Blood samples (from the cannula and finger pricks) will be then drawn for 3 h, and glucose and serum insulin, plasma glucagon, satiety markers, inflammation markers, amino acids et.al will be analysed.
The objective of the study is determining if different liquid protein consumed shortly before or with carbohydrate has different effects on metabolism.
And also we will compare the difference of white rice and white bread.
Determining the consuming time effect, milk protein type and carbohydrate type on glycaemic and insulinaemic are critical for the provision of dietary advice and formulation of public health guidelines.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Chinese ethnicity
- Age between 21-40 years
- Not on prescription medication known to affect glucose and satiety related metabolism
- Do not partake in sports at the competitive and/or endurance levels
- Weight of at least 45kg
- Body mass index between 18.0 to 24.9 kg/m2
- Normal blood pressure (120/80 mmHg)
Exclusion Criteria: Smoker
- fasting blood glucose>5.5 mmol/L
- Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
- Allergic or intolerant to foods presented in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Bread and water
co-ingestion control session
|
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
|
Experimental: bread with cow milk co-ingestion
co-ingestion bread with cow milk
|
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
|
Experimental: bread with soy milk co-ingestion
co-ingestion bread with soy milk
|
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
|
Experimental: preload cow milk
preload cow milk 30 min, then bread
|
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
|
Experimental: preload soy milk
preload soy milk 30 min, then bread
|
The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose response of different treatments
Time Frame: 3.5 hrs post consumption
|
The blood glucose will be measured by Hemocue 201 from finger prick.
Venous blood will be collected at the same time points.
|
3.5 hrs post consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying rate
Time Frame: 2 hours post consumption
|
Measurement of gastric emptying rate using real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC).
Ultrasound measurements will be taken with subjects in a supine position during fasting, then at 15-30 min intervals after consumption of the test meal.
|
2 hours post consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 28, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
May 30, 2014
Study Record Updates
Last Update Posted (Estimate)
February 2, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/00036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Bread, Soy milk and cow milk
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Mead Johnson NutritionBeijing Kangchen TechnologiesTerminated
-
Universidad Tecnologica de MexicoCompleted
-
University of PadovaCompletedHormone | Insulin Tolerance | Aminoacidaemia
-
Imperial College London Diabetes CentreUnknownGlucose Tolerance | Insulin SensitivityUnited Arab Emirates
-
Medical University of WarsawAusnutria Hyproca B.V.Not yet recruitingGastrointestinal Diseases | Infant Nutrition DisordersPoland
-
Wageningen UniversityCompleted
-
Ospedale San DonatoSoremartec Italia S.r.l.CompletedAttention Deficit and Disruptive Behavior Disorders | Lack of Satiety | Feeding BehaviorsItaly
-
Centre Hospitalier Universitaire VaudoisAgroscope Liebefeld-Posieux Research Station ALPUnknown
-
University of IdahoFree to Feed Inc.CompletedStress | Microbiome | Food Allergy in InfantsUnited States