Postprandial HyperglycemiaMAVIRE2NCT04175353
Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People
A study testing Dairy snack and Berry snack in people with Postprandial Hyperglycemia, run by University of Eastern Finland at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Dairy snack and Berry snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2016to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Home-dwelling
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Dairy snack, Berry snack
- Keywords
- older people, nutrition, dairy, berries, postprandial, glucose, insulin
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy snackDietary supplement
The effects of dairy snack are compared with orange juice.
Berry snackDietary supplement
The effects of two berry snacks are compared with berry soup.
| Study group | Role | What they receive |
|---|---|---|
| Dairy snack | Experimental | Drink high in milk protein, 250 ml Receives: Dietary Supplement: Dairy snack |
| Orange juice | Active comparator | Regular orange juice, 250 ml Receives: Dietary Supplement: Dairy snack |
| Berry snack 1 | Experimental | Bilberry-blackcurrant purée, 139 g Receives: Dietary Supplement: Berry snack |
| Berry snack 2 | Experimental | Lingonberry purée, 122 g Receives: Dietary Supplement: Berry snack |
| Berry soup | Active comparator | Bilberry soup, 250 ml Receives: Dietary Supplement: Berry snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glucose
Changes in plasma glucose concentration within 3 hrs after meal
Measured: 3 hrs
Change in postprandial insulin
Changes in plasma insulin concentration within 3 hrs after meal
Measured: 3 hrs
Secondary outcomes (3)
Change in postprandial free fatty acids
Changes in plasma free fatty acid concentration within 3 hrs after meal
Measured: 3 hrs
Change in postprandial satiety scores assessed by using visual analogy scales
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.
Measured: 3 hrs
Heart rate variability
Electrocardiography monitoring for assessment of several variables of heart rate variability
Measured: 3 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Feb 2016
- Primary completion2 Jun 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riitta Törrönen, PhD, Principal investigator, University of Eastern Finland, Institute of Public Health and Clinical NutritionMarjukka Kolehmainen, Professor, Principal investigator, University of Eastern Finland, Institute of Public Health and Clinical NutritionMika Tarvainen, PhD, Principal investigator, University of Eastern Finland, Department of Applied Physics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175353
- Sponsor's protocol ID
- MAVIRE2 247124
- Other IDs
- 4249/31/2014
- Acronym
- MAVIRE2
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torronen R, Jarvinen S, Kolehmainen M. Postprandial glycemic responses to a high-protein dairy snack and energy-enriched berry snacks in older adults. Clin Nutr ESPEN. 2022 Oct;51:231-238. doi: 10.1016/j.clnesp.2022.08.026. Epub 2022 Aug 30.
PubMed 36184209
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Food Solutions for Improving Nutrition and Well-being in Older People: Effects on Postprandial Responses
- ClinicalTrials.gov ID
- NCT04175353
- Acronym / sponsor ID
- MAVIRE2 / MAVIRE2 247124
- Conditions
- Postprandial Hyperglycemia
- Keywords
- older people, nutrition, dairy, berries, postprandial, glucose, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Jun 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dairy snack | Experimental | Dietary Supplement: Dairy snackDrink high in milk protein, 250 ml |
| Orange juice | Active comparator | Dietary Supplement: Dairy snackRegular orange juice, 250 ml |
| Berry snack 1 | Experimental | Dietary Supplement: Berry snackBilberry-blackcurrant purée, 139 g |
| Berry snack 2 | Experimental | Dietary Supplement: Berry snackLingonberry purée, 122 g |
| Berry soup | Active comparator | Dietary Supplement: Berry snackBilberry soup, 250 ml |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Home-dwelling
Key exclusion criteria (6 listed)
- Smoking
- Type 1 diabetes
- Type 2 diabetes treated with oral medications or insulin
- Cognitive impairment
- Antibiotic medication within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy snackThe effects of dairy snack are compared with orange juice. | Dietary supplement | Dairy snack, Orange juice |
| Berry snackThe effects of two berry snacks are compared with berry soup. | Dietary supplement | Berry snack 1, Berry snack 2, Berry soup |
Primary outcome
Change in postprandial glucose
Time frame: 3 hrs
Changes in plasma glucose concentration within 3 hrs after meal
Change in postprandial insulin
Time frame: 3 hrs
Changes in plasma insulin concentration within 3 hrs after meal
3 secondary outcomes
Change in postprandial free fatty acids
Time frame: 3 hrs
Change in postprandial satiety scores assessed by using visual analogy scales
Time frame: 3 hrs
Heart rate variability
Time frame: 3 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 36184209Torronen R, Jarvinen S, Kolehmainen M. Postprandial glycemic responses to a high-protein dairy snack and energy-enriched berry snacks in older adults. Clin Nutr ESPEN. 2022 Oct;51:231-238. doi: 10.1016/j.clnesp.2022.08.026. Epub 2022 Aug 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riitta Törrönen, PhD principal investigator
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Marjukka Kolehmainen, Professor principal investigator
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Mika Tarvainen, PhD principal investigator
University of Eastern Finland, Department of Applied Physics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy snack and Berry snack in people with Postprandial Hyperglycemia, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial glucose (time frame: 3 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.