The Effect of Beverages Varying in Protein Quantity on Appetite and Energy Intake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anestis Dougkas, Lund University
ClinicalTrials.gov Identifier:
NCT01849302
First received: April 30, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Beverages varying in macronutrient content on appetite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Acute Effect of Beverages Varying in Macro-nutrient Content on Subjective Appetite Ratings and ad Libitum Energy Intake in Healthy Subjects

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Changes from baseline in perceived appetite and satiety [ Time Frame: Assessed every 30 min for 270 min after each of the seven beverages which are served at least one week apart (7 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Ad libitum energy intake [ Time Frame: Energy intake is assessed 210 min after the 7 test beverages, which are served one week apart. ] [ Designated as safety issue: No ]
    Energy intake is assessed by ad libitum hot pasta meal provided 210 min after the test beverages, 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

  • Changes from baseline in the postprandial concentration of satiety hormones [ Time Frame: Assessed at 6 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks) ] [ Designated as safety issue: No ]
    Blood samples (2 ml) are collected 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. 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.

  • Hedonic ratings and palatability of the test beverages and meals [ Time Frame: Assessed immediately after consumption of the 7 test beverages and pasta meal (7 weeks) ] [ Designated as safety issue: No ]
    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.

  • Changes from baseline in the postprandial concentration of glucose [ Time Frame: Assessed at 7 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High protein/ High fat beverage

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

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: High protein/ Normal CHO beverage

Beverage based on milk protein: 1.8 MJ, 40 E% Protein, 47 E% CHO

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: Low protein/ High fat beverage

Beverage based on milk protein: 1.8 MJ, 9 E% Protein, 63 E% fat

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: Low protein/ High CHO beverage

Beverage based on milk protein: 1.8 MJ, 9 E% Protein, 71 E% CHO

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: Normal protein/ Normal CHO beverage

Beverage based on milk protein: 1.8 MJ, 24 E% Protein, 50 E% CHO

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: Normal protein/Normal CHO beverage

Beverage based on milk protein: 1.8 MJ, 24 E% Protein, 50 E% CHO

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite
Experimental: Normal protein/Normal CHO beverage

Beverage based on milk protein: 1.8 MJ, 24 E% Protein, 50 E% CHO

Acute effect of beverages varying in macronutrient content on appetite and energy intake

Dietary Supplement: Beverages varying in macronutrient content on appetite
In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
Other Name: Beverages varying in macronutrient content on appetite

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females
  • Age range 18-50 years
  • Normal weight and overweight people as classified by BMI:22-27.9 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 transferase > 1.9 μkat / L
  • Alanine transaminase > 1.1 μkat / L
  • Cholesterol > 6.5 mmol/L
  • Triglycerides > 2.0 mmol/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849302

Locations
Sweden
Department of Applied Nutrition and Food Chemistry
Lund, Skane, Sweden, 221 00
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anestis Dougkas, PhD Lund University
  More Information

No publications provided

Responsible Party: Anestis Dougkas, Postdoctoral Research Fellow, Lund University
ClinicalTrials.gov Identifier: NCT01849302     History of Changes
Other Study ID Numbers: 2012/6
Study First Received: April 30, 2013
Last Updated: February 25, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Appetite
Satiety hormones
Dietary Protein

ClinicalTrials.gov processed this record on October 20, 2014