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Effect of Milk Ingredients on Glucose Regulation and Inflammation

Primary Purpose

Glucose Regulation, Low-grade Inflammation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
nutrient-enriched milk
regular milk
Sponsored by
NIZO Food Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glucose Regulation focused on measuring dairy, glucose, inflammation

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 28-35 kg/m2
  • Waist circumference >102 cm
  • Healthy as assessed by the NIZO lifestyle and health questionnaire and results of the pre-study safety laboratory tests.
  • Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
  • Habitual consumption of dairy products as assessed by dietary questionnaire
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with study procedures
  • Access to internet
  • Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years.
  • Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
  • Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous or inhalatory administration of substances
  • Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal strictures
  • Medical drug use; antibiotics, laxatives, glucose lowering drugs, insulin; all medication with an inflammation inhibiting effect (e.g. NSAIDS, corticosteroids) and/or an effect on blood coagulation (e.g. coumarins, inhibitors of thrombin or factor Xa, acetylsalicylic acid, antidepressants from the group of serotonin reabsorption inhibitors, tranexamin acid)
  • Mental status that is incompatible with the proper conduct of the study
  • A self-reported reported food allergy or sensitivity (wheat, milk, lactose, eggs, nuts, etc)
  • Alcohol consumption > 28 units/week and 4/day
  • Exercise > 3 hours/week
  • Smoking >20 cigarettes/day
  • Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening
  • Reported slimming or medically prescribed diet
  • Reported vegan or macrobiotic life-style
  • Recent blood donation (<1 month prior to Day 01 of the study)
  • Not willing or afraid to give up blood donation during the study
  • Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner

Sites / Locations

  • NIZO food research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

nutrient-enriched milk

regular milk

Arm Description

consumption of 250 ml three times per day

consumption of 250 ml three times per day

Outcomes

Primary Outcome Measures

change in fasting blood glucose
change in fasting plasma interleukin-6 (IL-6)

Secondary Outcome Measures

postprandial area under the curve for plasma glucose
change in fasting insulin
postprandial area under the curve for plasma insulin
postprandial area under the curve for plasma IL-6

Full Information

First Posted
December 10, 2013
Last Updated
September 8, 2014
Sponsor
NIZO Food Research
Collaborators
FrieslandCampina
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1. Study Identification

Unique Protocol Identification Number
NCT02011672
Brief Title
Effect of Milk Ingredients on Glucose Regulation and Inflammation
Official Title
Effect of Milk Ingredients on Glucose Regulation and Inflammation in Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NIZO Food Research
Collaborators
FrieslandCampina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation. Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects. Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home. Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Regulation, Low-grade Inflammation
Keywords
dairy, glucose, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nutrient-enriched milk
Arm Type
Experimental
Arm Description
consumption of 250 ml three times per day
Arm Title
regular milk
Arm Type
Placebo Comparator
Arm Description
consumption of 250 ml three times per day
Intervention Type
Other
Intervention Name(s)
nutrient-enriched milk
Intervention Type
Other
Intervention Name(s)
regular milk
Primary Outcome Measure Information:
Title
change in fasting blood glucose
Time Frame
baseline and 7 weeks
Title
change in fasting plasma interleukin-6 (IL-6)
Time Frame
baseline and 7 weeks
Secondary Outcome Measure Information:
Title
postprandial area under the curve for plasma glucose
Time Frame
7 weeks
Title
change in fasting insulin
Time Frame
7 weeks
Title
postprandial area under the curve for plasma insulin
Time Frame
7 weeks
Title
postprandial area under the curve for plasma IL-6
Time Frame
7 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 28-35 kg/m2 Waist circumference >102 cm Healthy as assessed by the NIZO lifestyle and health questionnaire and results of the pre-study safety laboratory tests. Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day) Habitual consumption of dairy products as assessed by dietary questionnaire Voluntary participation Having given written informed consent Willing to comply with study procedures Access to internet Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned Exclusion Criteria: Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous or inhalatory administration of substances Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal strictures Medical drug use; antibiotics, laxatives, glucose lowering drugs, insulin; all medication with an inflammation inhibiting effect (e.g. NSAIDS, corticosteroids) and/or an effect on blood coagulation (e.g. coumarins, inhibitors of thrombin or factor Xa, acetylsalicylic acid, antidepressants from the group of serotonin reabsorption inhibitors, tranexamin acid) Mental status that is incompatible with the proper conduct of the study A self-reported reported food allergy or sensitivity (wheat, milk, lactose, eggs, nuts, etc) Alcohol consumption > 28 units/week and 4/day Exercise > 3 hours/week Smoking >20 cigarettes/day Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening Reported slimming or medically prescribed diet Reported vegan or macrobiotic life-style Recent blood donation (<1 month prior to Day 01 of the study) Not willing or afraid to give up blood donation during the study Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives Not having a general practitioner Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alwine Kardinaal, PhD
Organizational Affiliation
NIZO Food Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIZO food research
City
Ede
Country
Netherlands

12. IPD Sharing Statement

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Effect of Milk Ingredients on Glucose Regulation and Inflammation

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