- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175353
Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People (MAVIRE2)
November 22, 2019 updated by: University of Eastern Finland
Tailored Food Solutions for Improving Nutrition and Well-being in Older People: Effects on Postprandial Responses
Malnutrition or its risk is common among older people.
To maintain adequate nutrition, increased meal frequency is important.
In addition to main meals, regular consumption of nutrient- and energy-dense snacks is recommended.
The study examines the post-meal responses to dairy- and berry-based snacks tailored for older people.
The plasma concentrations of glucose, insulin and free fatty acids are measured during three hours after snack consumption.
In addition, subjective satiety responses and heart rate variability are recorded.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
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
-
-
-
Kuopio, Finland
- University of Eastern Finland
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Home-dwelling
Exclusion Criteria:
- Smoking
- Type 1 diabetes
- Type 2 diabetes treated with oral medications or insulin
- Cognitive impairment
- Antibiotic medication within the past 3 months
- Blood donation within the past month
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dairy snack
Drink high in milk protein, 250 ml
|
The effects of dairy snack are compared with orange juice.
|
Active Comparator: Orange juice
Regular orange juice, 250 ml
|
The effects of dairy snack are compared with orange juice.
|
Experimental: Berry snack 1
Bilberry-blackcurrant purée, 139 g
|
The effects of two berry snacks are compared with berry soup.
|
Experimental: Berry snack 2
Lingonberry purée, 122 g
|
The effects of two berry snacks are compared with berry soup.
|
Active Comparator: Berry soup
Bilberry soup, 250 ml
|
The effects of two berry snacks are compared with berry soup.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postprandial glucose
Time Frame: 3 hrs
|
Changes in plasma glucose concentration within 3 hrs after meal
|
3 hrs
|
Change in postprandial insulin
Time Frame: 3 hrs
|
Changes in plasma insulin concentration within 3 hrs after meal
|
3 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postprandial free fatty acids
Time Frame: 3 hrs
|
Changes in plasma free fatty acid concentration within 3 hrs after meal
|
3 hrs
|
Change in postprandial satiety scores assessed by using visual analogy scales
Time Frame: 3 hrs
|
Visual analogue scales (VAS) are used to assess satiety and other related subjective sensations (fullness, hunger, desire to eat, alertness) within 3 hrs after meal.
Each VAS consists of a 100-mm horizontal line anchored with verbal descriptions at each end expressing the weakest (0 mm) or strongest (100 mm) statement of sensation.
Results are scores between 0 and 100.
|
3 hrs
|
Heart rate variability
Time Frame: 3 hrs
|
Electrocardiography monitoring for assessment of several variables of heart rate variability
|
3 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Riitta Törrönen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition
- Principal Investigator: Marjukka Kolehmainen, Professor, University of Eastern Finland, Institute of Public Health and Clinical Nutrition
- Principal Investigator: Mika Tarvainen, PhD, University of Eastern Finland, Department of Applied Physics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
February 1, 2016
Primary Completion (Actual)
June 2, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
November 14, 2019
First Submitted That Met QC Criteria
November 22, 2019
First Posted (Actual)
November 25, 2019
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 22, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAVIRE2 247124
- 4249/31/2014 (Other Grant/Funding Number: Tekes)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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