Breakfast Test Products and Acute Satiety Scores

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

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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

Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are more overweight than underweight people in the world. This is partly caused by increased energy, or food intake. One of the physiological factors regulating the food intake pattern is satiety. Though the regulation of food intake has been studied quite extensively, the underlying mechanisms are not well elucidated yet and still new factors involved in this regulation are being found. Therefore, in this study the investigators aim to develop an in vitro screening tool combined with an in silico model for prediction of satiety, for cost- and time - effective screening of satiating properties of new and existing complex food products and (functional) ingredients, based on actual satiety scores measured. A second aim of the Wholegrain Satiety project is to evaluate satiating properties of different types of wholegrain breads and other oat based products, both for validation purposes and to strengthen the scientific evidence for health benefits of wholegrain products. As part of this study, acute satiety scores after consumption of various breakfast products in well-controlled clinical conditions will be compared with satiety scores obtained in 'at home' test conditions.

Objective: The current study aims to compare the acute satiety effect of carbohydrate breakfast products.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.

NCT01666561

Food Intake Satiety

COMPLETED NA

The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake

NCT01666574

Food Intake Satiety

COMPLETED NA

Oat Breakfast Satiety Study

NCT01372683

Subjective Appetite and Satiety Subjective Energy Levels

COMPLETED PHASE4

The Effect of Fatty Acid Composition on Energy Intake and Satiety

NCT00242021

Obesity

COMPLETED NA

Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal

NCT04788069

Energy Intake Appetite Regulation

COMPLETED NA

Detailed Description

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

In the present study the investigators will conduct a clinical trial in which a standard protocol will be used to examine five different breakfasts (different in type: breakfast cereals and bread, and macronutrient composition) with satiating ingredients which will reveal actual human satiety scores. The visual analogue scales used for determination of satiety feelings is an accepted method by EFSA and studied extensively. It is used by TNO in an earlier carbohydrate containing breakfast experiment.

Subjects may feel and eat differently at home. Especially since supervision by a researcher is known to influence behavior of participants. Self-measuring has the potential of giving more reliable estimates of intervention effects. Therefore, it is interesting to repeat the tests that are performed in the clinical unit, in an 'at home' condition, because that is the place consumers eat their breakfast habitually (= ecological validity).

Study design: The study is designed as an open, randomized, controlled, cross-over trial.

Study population: Forty healthy, lean and overweight, non-restrained eating women.

Intervention: The intervention consists of five different normal breakfasts (normal amount, about 243-355 kCal; bread, cooked oatmeal, cereal meal, fried egg with bread) provided as a breakfast in the metabolic ward and at home.

Main study parameters/endpoints: Satiety scores will be obtained with visual analogue rating scales (VAS). Subjects will rate hunger feelings, fullness feelings, satiety feelings, desire to eat and rate their prospective food consumption, before and multiple times after consumption of a breakfast. A test session lasts for four hours (t = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes).

In the controlled conditions at TNO, finger pricks will be performed at t = 0, 30, 60, 90 and 120 minutes after breakfast consumption to measure blood glucose.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will consume prescribed, standardized breakfast products; five times at a clinical unit and five times at home. No risk is associated with intake of the test products. The VAS questionnaire will be filled in on the laptop multiple times on all test days (at home and at the clinic). No risk or real burden is of concern in this study. Subjects will perform finger pricks five times in each controlled session at TNO, what is known as a minimally invasive technique to obtain drops of blood.

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

NONE

Study Groups

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

TNO whole wheat bread yeast basis

NBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at TNO

Group Type EXPERIMENTAL

whole wheat bread yeast basis

Intervention Type OTHER

TNO whole wheat sourdough bread

NBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water. at TNO

Group Type ACTIVE_COMPARATOR

whole wheat sourdough bread

Intervention Type OTHER

TNO Oatmeal

PepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams of water and consumed with 307 grams of skimmed milk at TNO

Group Type EXPERIMENTAL

Oatmeal

Intervention Type OTHER

TNO original Cheerios

PepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at TNO

Group Type ACTIVE_COMPARATOR

Cheerios

Intervention Type OTHER

TNO standard breakfast

TNO breakfast: one slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size).

The breakfast is consumed at TNO

Group Type EXPERIMENTAL

standard breakfast

Intervention Type OTHER

Home whole wheat bread yeast basis

NBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home

Group Type EXPERIMENTAL

whole wheat bread yeast basis

Intervention Type OTHER

Home whole wheat sourdough bread

NBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home

Group Type ACTIVE_COMPARATOR

whole wheat sourdough bread

Intervention Type OTHER

Home Oatmeal

PepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams\* of water and consumed with 307 grams of skimmed milk at home

Group Type EXPERIMENTAL

Oatmeal

Intervention Type OTHER

Home original Cheerios

PepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at home

Group Type ACTIVE_COMPARATOR

Cheerios

Intervention Type OTHER

Home standard breakfast

one slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size).

The breakfast is consumed at home

Group Type EXPERIMENTAL

standard breakfast

Intervention Type OTHER

Interventions

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

whole wheat bread yeast basis

Intervention Type OTHER

Oatmeal

Intervention Type OTHER

Cheerios

Intervention Type OTHER

whole wheat sourdough bread

Intervention Type OTHER

standard breakfast

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. Female subjects aged 18-50 years;
2. BMI: 22-32 kg/m2;
3. Written consent regarding participation after full information regarding all details of the study;
4. Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch; used to consume dietary fibres; like the test products (P9619 F02));
5. Normal dietary eating behaviour (non-restrained eaters, estimated with the Dutch Eating Behaviour Questionnaire; P9619 F06);
6. Healthy as assessed by the Health and Lifestyle questionnaire (P9619 F02);
7. Subjects with a normal dietary fibre intake (between 10-30 grams/day) (P9619 F07);
8. Voluntary participation;
9. Willing to comply with study procedures;
10. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;
11. Have a laptop with adequate internet access at home and experience how to use it, and willing to use and bring it to TNO.

Exclusion Criteria

1. On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders;
2. Reported postmenopausal;
3. Having menstruation problems, e.g. PCOS;
4. Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.);
5. On-going use of any slimming preparations;
6. Any kind of dysfunction of digestive tract, food allergies/intolerances related to the supplied test products (like gluten intolerance), chronic constipation, recent/actual gastroenteritis;
7. Reported unexplained weight loss or gain of \> 2 kg in the three months prior to the pre-study screening
8. Smoking;
9. Subjects with a high level of physical activity (\> 5h intense sporting activity/week);
10. Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink);
11. Physical, mental or practical limitations in using computerized systems;
12. Partner or first or second-degree relative from TNO personnel stationed at TNO Zeist.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes