Brief Summary

Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion adults being overweight. Consumption of foods that can affect appetite by increasing satiety could regulate the total energy intake and thus body weight. There is data suggesting that the macronutrient composition of the foods and especially protein content may have a potent role on satiety. However, it is difficult to pinpoint the optimum quantity needed to observe significant effects of protein on satiety. The research project is dedicated to identify which food components \[proteins, carbohydrates (CHO), fats\] and the optimized protein quantity needed to accelerate satiation, suppress appetite and extend satiety until hunger appears again. It is hypothesized that the consumption of protein-enriched meals will induce a reduction in hunger through the impact on gut hormones and peptides that are closely related to the short-term regulation of food intake.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline

Completed

Started Mar 2013

Shorter than P25 for not_applicable obesity

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

March 1, 2013

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

April 30, 2013

Last Update Submit

March 6, 2016

Conditions

Obesity

Keywords

AppetiteSatiety hormonesDietary Protein

Outcome Measures

Primary Outcomes (1)

Changes from baseline in perceived appetite and satiety
The appetite profile is assessed using validated Visual Analogue Scales (VAS) ratings (i.e hunger, fullness, desire to eat, prospective food consumption). The Questionnaires are performed electronically in personal laptops using the Adaptive Visual Analogue Scales (AVAS) software.
Assessed every 30 min for 270 min after each of the seven beverages which are served at least one week apart (7 weeks)

Secondary Outcomes (4)

Ad libitum energy intake
Energy intake is assessed 210 min after the 7 test beverages, which are served one week apart.
Changes from baseline in the postprandial concentration of satiety hormones
Assessed at 6 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks)
Hedonic ratings and palatability of the test beverages and meals
Assessed immediately after consumption of the 7 test beverages and pasta meal (7 weeks)
Changes from baseline in the postprandial concentration of glucose
Assessed at 7 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks)

Study Arms (7)

High protein/ High fat beverage

EXPERIMENTAL

Beverage based on milk protein: 1.8 MJ, 40 E% Protein, 42 E% fat Acute effect of beverages varying in macronutrient content on appetite and energy intake