Effect of Milk Ingredients on Glucose Regulation and Inflammation

NIZO Food Research

Status

Completed

Conditions

Low-grade Inflammation

Glucose Regulation

Treatments

Other: regular milk

Other: nutrient-enriched milk

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02011672

NL46103.081.13

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

50 to 65 years old

Volunteers

Accepts 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