Glycemic and Appetite Effects of a Pre-meal Whey-Protein Microgel

NCT06593769 | Completed

• 1 other identifier: 2401CLI
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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:

• post-prandial glucose
• appetite This is an open-label study in 18 overweight or obese participants. This study will be performed in one center, the Clinical Innovation Laboratory (CIL), Nestlé Research, Lausanne. Participants will be screened and randomly assigned to 1 of 2 sequences of consumption. Enrolled participants will then consume the test product, or placebo, pre-breakfast and pre-lunch for four days and then crossover to the other product, over a period of 12 days.

Conditions

Glucose Metabolism; Appetite Regulation

Keywords

glucose; appetite; proteins

Outcome Measures

Primary Outcomes (1)

• Post-prandial glucose - by continuos glucose measurement software

  The effect of a pre-meal intake of WPM versus placebo on PPG response after a standardized meal in participants with BMI of 27 - 35 kg/m2.

  V2 (day 1), V3 (day 5), V4 (day 12)

Secondary Outcomes (10)

• Appetite regulation - through a VAS questionnaire

  V2 (day 1), V3 (day 5), V4 (day 12)

• Appetite regulation - composite score - through a VAS questionnaire

  V2 (day 1), V3 (day 5), V4 (day 12)

• Ad libitum food intake - weighted on the scale

  V2 (day 1), V3 (day 5), V4 (day 12)

• Effect of the intervention on the post-prandial glucose after an ad libitum lunch

  V2 (day 1), V3 (day 5), V4 (day 12)

• Mean daily glucose, intervention vs placebo - by continuos glucose measurement software

  Day 2 (08:00 AM) to day 5 (08:00 AM) (3 days in total)

Study Arms (2)

Randomization sequence 1

OTHER

Whey-protein microgel (day 2 -5); placebo (water) (day 9 to day 12) Crossover design - all participants will undergo the same experimental conditions

Dietary Supplement: whey-protein microgel; Other: Placebo

Randomization sequence 2

OTHER

Placebo (water) (day 2 -5); whey-protein microgel (day 9 to day 12) Crossover design - all participants will undergo the same experimental conditions

Dietary Supplement: whey-protein microgel; Other: Placebo

Interventions

whey-protein microgel DIETARY_SUPPLEMENT

The product used in this study is a liquid 125 mL whey protein microgel (WPM) formulation that will be delivered in a ready-to-drink formulation. The WPM is dairy based and, aside from milk and lactose, no other allergens are present Whey proteins and caseinates are two major fractions of cow milk proteins.

Randomization sequence 1; Randomization sequence 2

Placebo OTHER

Water (isovoloumous amount)

Randomization sequence 1; Randomization sequence 2

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Laboratory

Lausanne, 1000, Switzerland

Location

Related Publications (1)

• Neeland IJ, Tsintzas K, Ahren B, Chilton RJ, Giorgetti A, Mondragon A, Ambiaux R, Migliavacca E, Philippe D, Aprikian O, Johansen OE. Short-term pre-meal whey protein microgel supplementation reduces postprandial glycemia and appetite in adults with overweight: An open-label randomised controlled trial. Obes Pillars. 2025 May 26;15:100183. doi: 10.1016/j.obpill.2025.100183. eCollection 2025 Sep.

  PMID: 40521305 DERIVED

Study Officials

• Nora Schneider

  Nestlé Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who meet the eligibility criteria will be randomized in 1:1 allocation ratio to one of the sequences (i.e., randomization groups): * sequence 1 = whey-protein microgel (WPM) in Day 2-Day 5 (period 1) and placebo in Day 9-Day 12 (period 2) * sequence 2 = placebo in period 1 and WPM in period 2. Randomization will be carried out using Medidata Rave RTSM.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: September 19, 2024
• Study Start: October 9, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 23, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)