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Effects of Sweetness on Neurocognitive Responses, Glycemia and Food Intake

2019年2月12日 更新者:Nikoleta Stamataki、University of Manchester

The Impact of Dietary Sweetness on Neurocognitive Responses to Visual Food Cues, Appetite and Physiological Parameters on Normal Weight Adults: a Pilot Study

This study aims to examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects.

調査の概要

詳細な説明

Excess consumption of caloric sweeteners, together with the high availability of palatable food cues are some of the factors for the alarming high rates of overweight and obesity. Although non-nutritive sweeteners (NNS) are used to decrease energy content of foods and beverages, there is an on-going debate on the relationship between NNS intake, obesity and cardiometabolic risk. Caloric sugars have a differing effect on physiological responses compared to NNS. However it is almost wholly unknown how NNS consumption affects eating behaviour and cognitive processes.

This study compares the performance on food related neurocognitive tasks following the consumption of the test preloads on 5 visits. In particular, sucrose, glucose, maltodextrin, water or a natural high potency sweetener from leaf extract will be ingested as single test agents in randomized order. Water will be used as a control for gastric distension and non-sweet, whereas maltodextrin will be used as a non-sweet control for carbohydrate content.

Participants will be asked to attend a screening visit at the Neuroscience and Psychiatry Unit of the University of Manchester on a morning after overnight fast. Participants' weight and height, fasting blood glucose and blood pressure will be measured. This will be followed by some questionnaires regarding general health status, weight and dieting history and eating behaviour.

Participants who satisfy the inclusion criteria, will be then invited to take part in the full study. This will require 5 separate visits at the University of Manchester, which will be scheduled between 11.30 and 13.30. Participants will have to attend these visits after having fasted for 3-4 hours and will be asked to have their regular breakfast in the morning before the testing session, and then not eat or drink anything else for 3-4 hours until they come in the lab for the testing session. Water will be allowed up to 1 hour prior to your testing session. Prior to each testing session participants will be asked to have the same breakfast, and they will have to provide a picture of the breakfast each time to ensure compliance.

The 5 visits correspond to 5 test beverages, both the participants and the investigators are blinded to the study treatments. Blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will also be asked to rate their feeling of hunger, fullness etc using visual analogue scales (VAS) at the same time points 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks. They are designed to capture behaviour in response to food cue presentation. This will last approximately 15 min.

Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. Each session is anticipated to last for approximately 1 hour.

研究の種類

介入

入学 (実際)

20

段階

  • 適用できない

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

      • Manchester、イギリス、M13 9PL
        • University of Manchester

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~40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

全て

説明

Inclusion Criteria:

  • Age 18 - 40 years
  • BMI between 18.5-24.9 kg/m2
  • DEBQ for restraint eating ≤ 3
  • Healthy - general good health
  • Currently not taking any medication (other than females taking the oral contraceptives)
  • Normal or corrected vision
  • Regular breakfast eaters (≥5 times per week)
  • Stable weight, ≤ 5 kg last 12 months
  • Fasting blood glucose ≤6.0 mmol/L
  • No self-reported food allergy or intolerance to foods supplied during the study
  • The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • The participant is able to read, comprehend and record information written in English.
  • A signed and dated written informed consent is obtained from the participant.

Exclusion Criteria:

  • Age under 18 years or over 40 years old.
  • BMI ≥25 kg/m2 and <18.5kg/m2
  • Subjects who are currently on a diet
  • Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
  • Subjects having breakfast fewer than 5 times per week.
  • Vegetarians, vegans.
  • Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
  • Subjects with eating disorders (binge eating disorder, bulimia etc)
  • Subjects who are currently experiencing anxiety or depression.
  • Subjects who do not have normal vision and do not correct it with glasses or contact lenses.
  • Participants who drink more than the NHS guidelines (14 units per week)
  • Female participants who are, or may be, pregnant, or currently lactating.
  • Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
  • Subjects who have aversions to foods related with the study.
  • Subjects with food allergies or intolerance related with the foods/ drinks of the study.
  • Habitual NNS consumers, >1 can of diet beverage or >1 table packet of sweeteners per week.
  • Fasting blood glucose measured > 6 mmol/L at screening visit, according to diabetes.co.uk recommendations.
  • The participant cannot read, comprehend and record information written in English.

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:基礎科学
  • 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:トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター:Water
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

実験的:Natural high potency sweetener from leaf extract
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

実験的:Glucose
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

実験的:Sucrose
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

実験的:Maltodextrin
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

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
Energy intake
時間枠:1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects energy intake (kcal) in healthy lean individuals.
1 hour
Appetite ratings
時間枠:1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects appetite ratings (VAS scales) in healthy lean individuals.
1 hour
Food-cue responses
時間枠:1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects food-cue responses (reaction times) in healthy lean individuals.
1 hour
Blood glucose levels
時間枠:1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects blood glucose levels (mmol/L) in healthy lean individuals.
1 hour

二次結果の測定

結果測定
メジャーの説明
時間枠
Hedonic ratings
時間枠:1 hour
Examine how participants rate the hedonic attributes of the test beverages (Sweetness, pleasantness, etc) and the meal
1 hour

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

協力者

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。

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 (実際)

2018年4月26日

一次修了 (実際)

2018年10月15日

研究の完了 (実際)

2018年11月15日

試験登録日

最初に提出

2018年10月8日

QC基準を満たした最初の提出物

2018年10月16日

最初の投稿 (実際)

2018年10月18日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月15日

QC基準を満たした最後の更新が送信されました

2019年2月12日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2310 (CTEP)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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