Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans
Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
1 other identifier
interventional
6
1 country
1
Brief Summary
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2021
CompletedNovember 22, 2022
November 1, 2022
1 month
April 9, 2021
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial glucose response
Incremental area under the blood glucose curve after each meal
From start of meal (0 min) to 120 min postprandially
Secondary Outcomes (1)
Glycemic variability
24 hour cycles
Study Arms (1)
Drink intervention
OTHERPlacebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order.
Interventions
Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.
Eligibility Criteria
You may qualify if:
- BMI 25-29.9 kg/m\^2
- HOMA-IR \< 2.5
- Fasting glucose \< 6.1 mmol/L
- Stable weight since 3 months
- Access to iPhone with Bluetooth 4.0 and iOS 13 or later
You may not qualify if:
- Diabetes
- Pharmacological treatment known to interfer with metabolism
- Antibiotics treatment the latest 3 months
- Vegetarian/Vegan diet
- Use of tobacco
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DoubleGood ABlead
- starScience GmbHcollaborator
Study Sites (1)
Aventure AB
Lund, 223 63, Sweden
Related Publications (1)
Samigullin A, Humpert PM, Ostman E. Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium. Front Med Technol. 2022 Aug 18;4:931837. doi: 10.3389/fmedt.2022.931837. eCollection 2022.
PMID: 36062264RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Elin Ostman, PhD
Aventure AB
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 19, 2021
Study Start
April 20, 2021
Primary Completion
May 26, 2021
Study Completion
May 26, 2021
Last Updated
November 22, 2022
Record last verified: 2022-11