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

NCT ID: NCT01849302

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

Normal protein/ Normal CHO beverage 1

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

Normal protein/Normal CHO beverage 2

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

Normal protein/Normal CHO beverage 3

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

Group Type EXPERIMENTAL

Beverages varying in macronutrient content on appetite

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anestis Dougkas

Postdoctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anestis Dougkas, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Applied Nutrition and Food Chemistry

Lund, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26791555 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012/6

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oat Breakfast Satiety Study
NCT01372683 COMPLETED PHASE4