Effect of Milk Ingredients on Glucose Regulation and Inflammation

September 8, 2014 updated by: Alwine Kardinaal, NIZO Food Research

Effect of Milk Ingredients on Glucose Regulation and Inflammation in Overweight Subjects

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

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

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

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nutrient-enriched milk
consumption of 250 ml three times per day
Placebo Comparator: regular milk
consumption of 250 ml three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in fasting blood glucose
Time Frame: baseline and 7 weeks
baseline and 7 weeks
change in fasting plasma interleukin-6 (IL-6)
Time Frame: baseline and 7 weeks
baseline and 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
postprandial area under the curve for plasma glucose
Time Frame: 7 weeks
7 weeks
change in fasting insulin
Time Frame: 7 weeks
7 weeks
postprandial area under the curve for plasma insulin
Time Frame: 7 weeks
7 weeks
postprandial area under the curve for plasma IL-6
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46103.081.13

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.

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