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

NCT ID: NCT02573194

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Animal source of proteins

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

Group Type: EXPERIMENTAL

Breakfasts varying in protein source content on appetite

Intervention Type: 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.

Plant source of proteins

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

Group Type: EXPERIMENTAL

Breakfasts varying in protein source content on appetite

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Breakfasts varying in protein source content on appetite

Intervention Type: 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.

Low protein

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

Group Type: EXPERIMENTAL

Breakfasts varying in protein source content on appetite

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Anestis Dougkas

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anestis Dougkas, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Food for Health Science Center

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

FHSC

Identifier Type: -

Identifier Source: org_study_id