Effect of Milk Ingredients on Glucose Regulation and Inflammation

NCT02011672 | Completed

• 1 other identifier: NL46103.081.13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Regulation; Low-grade Inflammation

Keywords

dairy; glucose; inflammation

Outcome Measures

Primary Outcomes (2)

• change in fasting blood glucose

  baseline and 7 weeks

• change in fasting plasma interleukin-6 (IL-6)

  baseline and 7 weeks

Secondary Outcomes (4)

• postprandial area under the curve for plasma glucose

  7 weeks

• change in fasting insulin

  7 weeks

• postprandial area under the curve for plasma insulin

  7 weeks

• postprandial area under the curve for plasma IL-6

  7 weeks

Study Arms (2)

nutrient-enriched milk

EXPERIMENTAL

consumption of 250 ml three times per day

Other: nutrient-enriched milk

regular milk

PLACEBO COMPARATOR

consumption of 250 ml three times per day

Other: regular milk

Interventions

nutrient-enriched milk OTHER

nutrient-enriched milk

regular milk OTHER

regular milk

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NIZO Food Research: lead
• FrieslandCampina: collaborator

Study Sites (1)

NIZO food research

Ede, Netherlands

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alwine Kardinaal, PhD

  NIZO Food Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager Health

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

NL (1)