Clinical trial NCT01849302: The Effect of Beverages Varying in Protein Quantity on Appetite and Energy Intake
Official title: The Acute Effect of Beverages Varying in Macro-nutrient Content on Subjective Appetite Ratings and ad Libitum Energy Intake in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Appetite
Satiety hormones
Dietary Protein
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Changes from baseline in perceived appetite and satiety
timeFrame: 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:
measure: Ad libitum energy intake
timeFrame: Energy intake is assessed 210 min after the 7 test beverages, which are served one week apart.
measure: Changes from baseline in the postprandial concentration of satiety hormones
timeFrame: Assessed at 6 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks)
measure: Hedonic ratings and palatability of the test beverages and meals
timeFrame: Assessed immediately after consumption of the 7 test beverages and pasta meal (7 weeks)
measure: Changes from baseline in the postprandial concentration of glucose
timeFrame: Assessed at 7 points in time over the morning of each of the 7 test days, which are separated by 1 week (7 weeks)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Applied Nutrition and Food Chemistry
state: Skane
Study officials:
affiliation: Lund University
name: Anestis Dougkas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougkas A, Ostman E. Protein-Enriched Liquid Preloads Varying in Macronutrient Content Modulate Appetite and Appetite-Regulating Hormones in Healthy Adults. J Nutr. 2016 Mar;146(3):637-45. doi: 10.3945/jn.115.217224. Epub 2016 Jan 20.