Overview

This trial has been completed.

Condition obesity
Treatments whole wheat bread yeast basis, oatmeal, cheerios, whole wheat sourdough bread, standard breakfast
Phase phase 2
Sponsor TNO
Collaborator Nederlands Bakkerij Centrum
Start date October 2015
End date December 2015
Trial size 32 participants
Trial identifier NCT02575131, 9619

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(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
whole wheat bread yeast basis
(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
whole wheat sourdough bread
(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
oatmeal
(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
cheerios
(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
standard breakfast
(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
whole wheat bread yeast basis
(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
whole wheat sourdough bread
(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
oatmeal
(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
cheerios
(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
standard breakfast

Primary Outcomes

Measure
Hunger and satiety feelings for different compositions of breakfasts
time frame: four hours

Secondary Outcomes

Measure
Level of control of the conduct (controlled at TNO versus less control at home)
time frame: Four hour follow-up on hunger and satiety feelings after each breakfast session
Blood glucose
time frame: two hours

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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.

Additional Information

Official title The Effect of Breakfast Test Products on Acute Satiety Scores in Different Test Conditions
Principal investigator Wilrike J Pasman, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by TNO.