The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake

Obesity Clinical Trial

Official title:

The Acute Effect of Breakfasts Varying in Protein Source Content on Subjective Appetite Ratings and Voluntary Energy Intake in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573194
• Other study ID #: FHSC
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: March 2, 2016
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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, the type of protein appears to play a role in satiety possibly due to the different balance of the amino acid profile.

The research project is dedicated to identify the source (animal or plant) 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 animal derived 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy males

• Age range 18-50 years

• Normal weight and overweight people as classified by BMI:20-29.9 kg/m2 (inclusive).

• Weight stable (within 3 kg) two months prior to study inclusion

• Understanding English well and feeling comfortable speaking it

Exclusion Criteria:

• Dietary protein consumption >25% energy from protein

• Had surgery in the previous 12 months

• Have suffered a myocardial infarction or stroke at any time

• Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting

• Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)

• Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease

• Any dietary restrictions or recently/currently on a weight reducing diet

• Irregular eating patterns or not regularly consuming breakfast

• Food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)

• Use of medication which affects food intake or behaviour (e.g. anti-depressants)

• Use of medication likely to affect taste, smell or appetite

• Eating restraint based on the three Factor Eating Questionnaire

• Use of any protein supplements

• A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men

• Smoking

• Athletes in training (>10 h exercise/week)

• Female that is breast-feeding, pregnant, or if of child-bearing potential and are not using effective contraceptive precautions

• Involvement in a study involving an experimental drug/medication within 3 months prior to entry of this study

• Blood pressure > 160/90 mmHg

• Vegan or Vegetarian

• Glucose > 6 mmol/L

• Gamma glutamyl transpeptidase (liver enzymes) > 1.9 µkat / L

• Alanine aminotransferase > 1.1 µkat / L

• Cholesterol > 6.5 mmol/L

• Triglycerides > 2.0 mmol/L

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Breakfasts varying in protein source content on appetite
In this randomized, within-subject study, subjects are asked to consume 4 iso-energetic and iso-volumetric puddings as breakfast (20% of estimated energy requirements) with varying distribution of protein sources. The objective is to identify the protein source and the distribution on suppressing appetite.

Locations

Country	Name	City	State
Sweden	Food for Health Science Center	Lund	Scania

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 until 240min and in paper form throughout the remaining of the study day.	Assessed every 30 min for 240 min and 60 min throughout the day after each of the four breakfasts which are served at least one week apart (4 weeks)	No
Secondary	Voluntary energy intake	Energy intake is assessed by voluntary hot meal ('Pytt I Panna', Swedish hash) provided 210 min after the test puddings, which are given as breakfast. Subjects are instructed to eat only until they feel comfortable satisfied and are given 25min to consume the meal. The total energy consumed is monitored.	Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.]	No
Secondary	Appetite and Satiety Hormones	Blood samples (2 ml) are collected into edetic acid (EDTA) treated tubes at 0 min (fasted blood sample), 30, 60, 90, 150 and 205 min (i.e. total of 6 samples) over the morning on each test day (separated by 1 week) to quantify the plasma concentrations of circulating appetite regulating hormones and amino acids. Protease inhibitors are added to the samples to reduce protein degradation. All samples are centrifuged at 4 C for 10 min at 2000 g after collection and are separated and stored in cryogenic vials at -80 C.	Assessed at 6 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)]	No
Secondary	Hedonic Ratings and Palatability of the Test Breakfasts and Meals	The palatability and hedonic ratings are assessed using validated Visual Analogue Scales (VAS) ratings (i.e appearance, taste, overall palatability). The Questionnaires are performed electronically in personal laptops using the Adaptive Visual Analogue Scales (AVAS) software.	Assessed immediately after consumption of the 4 test puddings and Swedish hash meal (4 weeks)	No
Secondary	Glucose measurements	Capillary blood samples are collected by finger-prick at 0 min (fasted blood sample), 30, 45, 60, 90, 150 and 205 min (i.e. total of 7 samples) over the morning on each test day (separated by 1 week) to quantify the glucose concentration using HemoCue Glucose System.	Assessed at 7 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)	No