このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Breakfast Test Products and Acute Satiety Scores

2016年10月18日 更新者：W.J. Pasman、TNO

The Effect of Breakfast Test Products on Acute Satiety Scores in Different Test Conditions

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

32

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • オランダ
    • Utrecht
      • Zeist、Utrecht、オランダ、3704HE
        • TNO Quality of Life

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～50年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
他の：whole wheat bread yeast basis
アクティブコンパレータ：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
他の：whole wheat sourdough bread
実験的：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
他の：オートミール
アクティブコンパレータ：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
他の：Cheerios
実験的：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
他の：標準的な朝食
実験的：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
他の：whole wheat bread yeast basis
アクティブコンパレータ：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
他の：whole wheat sourdough bread
実験的：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
他の：オートミール
アクティブコンパレータ：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
他の：Cheerios
実験的：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
他の：標準的な朝食

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Hunger and satiety feelings for different compositions of breakfasts
時間枠：four hours
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Level of control of the conduct (controlled at TNO versus less control at home)
時間枠：Four hour follow-up on hunger and satiety feelings after each breakfast session
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
Blood glucose
時間枠：two hours
In the controlled condition at TNO the blood glucose response will be monitored with finger pricks and direct blood glucose measurement.
two hours

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

TNO

協力者

Nederlands Bakkerij Centrum
PepsiCo, Inc.

捜査官

  • 主任研究者：Wilrike J Pasman, PhD、TNO

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年10月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2016年7月1日

試験登録日

最初に提出

2015年10月6日

QC基準を満たした最初の提出物

2015年10月11日

最初の投稿 (見積もり)

2015年10月14日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年10月19日

QC基準を満たした最後の更新が送信されました

2016年10月18日

最終確認日

2016年10月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 9619

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する