Status:
COMPLETED
Glycemic and Appetite Effects of a Pre-meal Whey-Protein Microgel
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Glucose Metabolism
Appetite Regulation
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
In this study, the investigators want to assess the effects of a short-term twice daily pre-meal consumption of a liquid whey-protein microgel formulation, when compared to placebo (i.e., water), on: ...
Detailed Description
This study aims to provide new insights, and confirm a number of previous observations related to the role of whey-protein microgel in supporting glycemic regulation and supporting appetite regulation...
Eligibility Criteria
Inclusion
- Males and females aged 45 - 70 years, at enrolment.
- Body mass index (BMI) ≥ 27 kg/m² but \< 35 kg/m².
- Healthy participants based on medical history.
- Able to understand and to sign a written informed consent prior to study enrolment.
- Willing and able to comply with the requirements for participation in this study.
Exclusion
- Any past or on-going diagnosed medical/surgical condition (i.e., diabetes, malignancy, gastrointestinal disease, chronic inflammatory condition, chronic kidney disease, cardiovascular disease, bleeding disorder) and/ or psychiatric condition (e.g. depression, psychotic disorders, chronic insomnia, eating disorder), which in the opinion of the site physician/investigator may risk participant's well-being/safety, impede participant compliance with study procedures or ability to complete the study and/or could confound the primary objectives of the study.
- Random plasma glucose ≥ 11.1 mmol/L or fasting plasma glucose ≥ 7.0 mmol/L (finger-prick point-of-care \[POC\] testing)
- HbA1c ≥ 6.5% (finger-prick POC testing)
- Known inborn errors of amino acid and protein metabolism.
- With planned/scheduled medical imaging procedure/s (magnetic resonance imaging \[MRI\], computed tomography \[CT\] scan, X-ray), or electrical heat (diathermy) treatment during the study period.
- Known or suspected allergies or intolerances to any of the ingredients of the nutritional formulation (i.e., milk, lactose) and the study meals.
- Known or suspected cutaneous hypersensitivity to adhesives, silicon, or plaster.
- Substantial changes in eating habits (i.e., switching from one dietary regimen to another) up to 30 days before enrolment.
- Anticipated change in usual physical activity levels during the study period (e.g., plans for undertaking new vigorous-intensity physical activity such as: jogging, running, carrying heavy objects or other loads upstairs, shoveling snow, participating in a fitness class, and fast swimming, that will lead to hard and fast breathing).
- Any chronic alcohol or drug abuse within the past year; specifically, alcohol intake \> 2 servings per day for males and \>1 serving per day for females. A serving corresponds to 0.35dl of liquor/strong alcohol, 1 dl of wine, or 3 dl of beer.
- Female participants who are pregnant, lactating and/or breastfeeding.
- Participants who refuse to be informed of incidental findings relevant to their health (e.g. abnormal laboratory results).
- Currently participating in another interventional study.
- Family or hierarchical relationships with the research team members.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06593769
Start Date
October 9 2024
End Date
December 23 2024
Last Update
February 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Innovation Laboratory
Lausanne, Switzerland, 1000