Breakfast Test Products and Acute Satiety Scores

NCT02575131 | Completed Phase 2

• 1 other identifier: 9619
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

satiety; overweight; breakfast; ecological validity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Level of control of the conduct (controlled at TNO versus less control at home)

  Four hour follow-up on hunger and satiety feelings after each breakfast session

• Blood glucose

  two hours

Study Arms (10)

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

Other: whole wheat bread yeast basis

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

Other: whole wheat sourdough bread

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

Other: Oatmeal

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

Other: Cheerios

TNO standard breakfast

EXPERIMENTAL

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

Other: standard breakfast

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

Other: whole wheat bread yeast basis

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

Other: whole wheat sourdough bread

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

Other: Oatmeal

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

Other: Cheerios

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: standard breakfast

Interventions

whole wheat bread yeast basis OTHER

Home whole wheat bread yeast basis; TNO whole wheat bread yeast basis

Oatmeal OTHER

Home Oatmeal; TNO Oatmeal

Cheerios OTHER

Home original Cheerios; TNO original Cheerios

whole wheat sourdough bread OTHER

Home whole wheat sourdough bread; TNO whole wheat sourdough bread

standard breakfast OTHER

Home standard breakfast; TNO standard breakfast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects aged 18-50 years;
• BMI: 22-32 kg/m2;
• Written consent regarding participation after full information regarding all details of the study;
• 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));
• Normal dietary eating behaviour (non-restrained eaters, estimated with the Dutch Eating Behaviour Questionnaire; P9619 F06);
• Healthy as assessed by the Health and Lifestyle questionnaire (P9619 F02);
• Subjects with a normal dietary fibre intake (between 10-30 grams/day) (P9619 F07);
• Voluntary participation;
• Willing to comply with study procedures;
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;
• Have a laptop with adequate internet access at home and experience how to use it, and willing to use and bring it to TNO.

You may not qualify if:

• 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;
• Reported postmenopausal;
• Having menstruation problems, e.g. PCOS;
• Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.);
• On-going use of any slimming preparations;
• Any kind of dysfunction of digestive tract, food allergies/intolerances related to the supplied test products (like gluten intolerance), chronic constipation, recent/actual gastroenteritis;
• Reported unexplained weight loss or gain of \> 2 kg in the three months prior to the pre-study screening
• Smoking;
• Subjects with a high level of physical activity (\> 5h intense sporting activity/week);
• 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);
• Physical, mental or practical limitations in using computerized systems;
• Partner or first or second-degree relative from TNO personnel stationed at TNO Zeist.

Sponsors & Collaborators

• TNO: lead
• Nederlands Bakkerij Centrum: collaborator
• PepsiCo, Inc.: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704HE, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 20122136 BACKGROUND

• 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.

  PMID: 7794869 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.

  PMID: 12833109 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.

  PMID: 22844645 RESULT

Related Links

• Prevalence of obesity

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilrike J Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Trials

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

NL (1)