Skip to main content
OpenTrials
Completed

NCT Number: NCT02011672

Effect of Milk Ingredients on Glucose Regulation and Inflammation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NIZO food research

Ede, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutrient-enriched milk

Other

regular milk

Other

Primary outcomes

  1. change in fasting blood glucose

    Time frame: baseline and 7 weeks

  2. change in fasting plasma interleukin-6 (IL-6)

    Time frame: baseline and 7 weeks

Secondary outcomes

  1. postprandial area under the curve for plasma glucose

    Time frame: 7 weeks

  2. change in fasting insulin

    Time frame: 7 weeks

  3. postprandial area under the curve for plasma insulin

    Time frame: 7 weeks

  4. postprandial area under the curve for plasma IL-6

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • FrieslandCampina

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.