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

NCT02573194 | Completed

• 1 other identifier: FHSC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Obesity

Keywords

Appetite; Amino acids; Protein Source

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 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)

Secondary Outcomes (4)

• Voluntary energy intake

  Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.]

• Appetite and Satiety Hormones

  Assessed at 6 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)]

• Hedonic Ratings and Palatability of the Test Breakfasts and Meals

  Assessed immediately after consumption of the 4 test puddings and Swedish hash meal (4 weeks)

• Glucose measurements

  Assessed at 7 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)

Study Arms (4)

Animal source of proteins

EXPERIMENTAL

Breakfast based on animal proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake

Dietary Supplement: Breakfasts varying in protein source content on appetite

Plant source of proteins

EXPERIMENTAL

Breakfast based on plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake

Dietary Supplement: Breakfasts varying in protein source content on appetite

Animal and plant source of proteins

EXPERIMENTAL

Breakfast based on both animal and plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake

Dietary Supplement: Breakfasts varying in protein source content on appetite

Low protein

EXPERIMENTAL

Breakfast very low in protein: 1700 kJ, 5 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake

Dietary Supplement: Breakfasts varying in protein source content on appetite

Interventions

Breakfasts varying in protein source content on appetite DIETARY_SUPPLEMENT

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.

Animal and plant source of proteins; Animal source of proteins; Low protein; Plant source of proteins

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age range 18-50 years
• Normal weight and overweight people as classified by BMI:20-29.9 kg/m2 (inclusive).
• Understanding English well and feeling comfortable speaking it

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Food for Health Science Center

Lund, Skåne County, 223 81, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anestis Dougkas, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 9, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

SE (1)