Nano-particulated and Alginate Whey Protein's Effects on Appetite - Food Structure Approaches Developed Within the StrucSat Project

Based on animal studies in mice, nano-particulated whey protein and high molecular weight whey protein-alginate coacervates are expected to have appetite reducing (and potentially also other) effects, which potentially may be beneficial for body weight management. In order to investigate these effects in humans, this study is divided into two parts (Part 1 and Part 2), of which the specific objectives are specified below:

Part 1: The objective of this part of the study is to examine if nano-particulated whey protein can reduce appetite compared with non-particulated whey protein.

Part 2: The objective of this part of the study is to examine if high molecular weight whey protein-alginate coacervates can reduce appetite compared to calcium alginate.

A double-blind, randomised crossover design with four arms divided into the two parts will be applied. After having successfully completed screening procedures, eligible participants will be invited to two separate appetite probe days with particulated whey protein followed by at least 14 days break followed by another two separate appetite probe days with the whey protein-alginate coacervates. The appetite probe days must be separated by at least 7 days, but there is no upper limit for days in between, as long as the participants remain weight stable and do not change diet or physical activity level significantly. The study includes a total of five visits to the study site.

For standardisation, 48 hours before the appetite probe days, the participants will be asked to consume a regular diet compliant to what they usually eat and no excessive alcohol consumption (not above 5 units and no alcohol at all from 8 pm the night before the appetite probe days) or intense physical activity is allowed. Within each part of the study, the participants will be instructed to consume similar meals the evening before the appetite probe days and the meal must be consumed at approximately the same time. The participants will also be instructed to go to bed at the same time in the evening prior to the appetite probe days. Additionally, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation. Furthermore, over the course of the study (from screening (visit 1) to completion of the last appetite probe day (visit 5)), the participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardisation criteria in a room away from the other participants before initiating each appetite probe day. Possible non-compliance with the standardisation will be judged whether to result in re-scheduling of the visit or to be recorded as a protocol deviation.