Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nederlands Bakkerij Centrum | OTHER |
| PepsiCo, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNO whole wheat bread yeast basis | Experimental | 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 |
|
| TNO whole wheat sourdough bread | Active Comparator | 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 |
|
| TNO Oatmeal | Experimental | 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 |
|
| TNO original Cheerios | Active Comparator | 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 |
|
| TNO standard breakfast | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole wheat bread yeast basis | Other |
| ||
| Oatmeal |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger and satiety feelings for different compositions of breakfasts | Response in hunger and satiety feelings due to breakfast consumption over time (four hours) will be measured with a visual analogue rating scale varying of no hunger (0 mm) to very hungry (100 mm) | four hours |
| Measure | Description | Time Frame |
|---|---|---|
| Level of control of the conduct (controlled at TNO versus less control at home) | The differences in hunger and satiety scores measured with visual analogue rating scales will be monitored for four hours after breakfast consumption at TNO (controlled setting) versus at home (less control) | Four hour follow-up on hunger and satiety feelings after each breakfast session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wilrike J Pasman, PhD | TNO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TNO Quality of Life | Zeist | Utrecht | 3704HE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20122136 | Background | Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29. | |
| 7794869 | Result | Raben A, Tagliabue A, Astrup A. The reproducibility of subjective appetite scores. Br J Nutr. 1995 Apr;73(4):517-30. doi: 10.1079/bjn19950056. |
| Label | URL |
|---|---|
| Prevalence of obesity | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
|
| Home whole wheat bread yeast basis | Experimental | 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 |
|
| Home whole wheat sourdough bread | Active Comparator | 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 |
|
| Home Oatmeal | Experimental | 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 |
|
| Home original Cheerios | Active Comparator | 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 |
|
| Home standard breakfast | Experimental | 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 |
|
| Other |
|
| Cheerios | Other |
|
| whole wheat sourdough bread | Other |
|
| standard breakfast | Other |
|
| Blood glucose | In the controlled condition at TNO the blood glucose response will be monitored with finger pricks and direct blood glucose measurement. | two hours |
| 12833109 | Result | Pasman WJ, Blokdijk VM, Bertina FM, Hopman WP, Hendriks HF. Effect of two breakfasts, different in carbohydrate composition, on hunger and satiety and mood in healthy men. Int J Obes Relat Metab Disord. 2003 Jun;27(6):663-8. doi: 10.1038/sj.ijo.0802284. |
| 22844645 | Result | Marschollek M, Gietzelt M, Schulze M, Kohlmann M, Song B, Wolf KH. Wearable sensors in healthcare and sensor-enhanced health information systems: all our tomorrows? Healthc Inform Res. 2012 Jun;18(2):97-104. doi: 10.4258/hir.2012.18.2.97. Epub 2012 Jun 30. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |