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The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control

Primary Purpose

Lack of Satiety, Hyperphagia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Almonds
Cheese Savouries
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lack of Satiety

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who have provided written informed consent.
  • Healthy female participants aged 18-55 years.
  • BMI of 18.5 - 30.0 kg/m2.
  • Regular breakfast eaters.
  • Not currently dieting to lose, gain or maintain weight.
  • Non-smokers.
  • Liking/acceptance of the study foods (≥4 on 7-point Likert scale).

Exclusion Criteria:

  • Taking medication known to affect appetite within past month and/or during the study.
  • Any known food allergies or food intolerances.
  • Participants who do not regularly eat breakfast.
  • Participants with low liking or acceptance of the study foods.
  • Participants currently dieting to lose, gain or maintain weight.
  • Reported history of or present eating disorder.
  • BMI <18.5 kg/m2 or >30 kg/m2.
  • Vegetarians.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Almond, then No Food, then Cheese Savouries

    Cheese Savouries then Almond, then No Food

    No Food, then Cheese Savouries, then Almond

    Cheese Savouries, then No Food, then Almond

    Almond, then Cheese Savouries, then No Food

    No Food, then Almond, then Cheese Savouries

    Arm Description

    Participants first received a mid-morning snack of almonds (0.9g/kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g/kg).

    Participants first received a mid-morning snack of cheese savouries (0.9g/kg). After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received no food.

    Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of almonds (0.9g/kg).

    Participants first received a mid-morning snack of cheese savouries (0.9g\kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds (0.9g\kg).

    Participants first received a mid-morning snack of almonds (0.9g\kg). After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g\kg). Finally, after another washout period participants received no food.

    Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g\kg).

    Outcomes

    Primary Outcome Measures

    Test Meal Energy Intake
    Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.

    Secondary Outcome Measures

    Food Preference
    Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator. Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008). 8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score. Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome.
    Appetite Sensations (Hunger)
    Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator. Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS). Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method. Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention. Higher AUC scores on hunger are interpreted as a worse outcome.
    24 Hour Energy Intake
    Measured reductions in total within-day energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart.

    Full Information

    First Posted
    June 4, 2015
    Last Updated
    January 25, 2017
    Sponsor
    University of Leeds
    Collaborators
    Almond Board of California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480582
    Brief Title
    The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control
    Official Title
    The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leeds
    Collaborators
    Almond Board of California

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an energy and weight matched comparator food or no food on measures of appetite control including appetite sensations, energy intake and food hedonics.
    Detailed Description
    Some individuals exhibit a weak satiety response to food and may be susceptible to overconsumption. Snack foods can be substantial contributors to daily energy intake, with different types of snacks exerting potentially different effects on satiety per calorie consumed. The current study will compare the effect of consuming different snack foods on measures of appetite control including appetite sensations, energy intake and food hedonics in women with a weak satiety response. In a crossover design, female participants will consume three different mid-morning snacks: raw almonds, savoury crackers or water. Appetite sensations, energy intake, food reward and craving will be assessed under controlled laboratory conditions. Satiety responsiveness will be determined using the satiety quotient (SQ).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lack of Satiety, Hyperphagia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Almond, then No Food, then Cheese Savouries
    Arm Type
    Experimental
    Arm Description
    Participants first received a mid-morning snack of almonds (0.9g/kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g/kg).
    Arm Title
    Cheese Savouries then Almond, then No Food
    Arm Type
    Experimental
    Arm Description
    Participants first received a mid-morning snack of cheese savouries (0.9g/kg). After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received no food.
    Arm Title
    No Food, then Cheese Savouries, then Almond
    Arm Type
    Experimental
    Arm Description
    Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of almonds (0.9g/kg).
    Arm Title
    Cheese Savouries, then No Food, then Almond
    Arm Type
    Experimental
    Arm Description
    Participants first received a mid-morning snack of cheese savouries (0.9g\kg). After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds (0.9g\kg).
    Arm Title
    Almond, then Cheese Savouries, then No Food
    Arm Type
    Experimental
    Arm Description
    Participants first received a mid-morning snack of almonds (0.9g\kg). After a washout period of 5 days, they then received a mid-morning snack of cheese savouries (0.9g\kg). Finally, after another washout period participants received no food.
    Arm Title
    No Food, then Almond, then Cheese Savouries
    Arm Type
    Experimental
    Arm Description
    Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds (0.9g/kg). Finally, after another washout period participants received a mid-morning snack of cheese savouries (0.9g\kg).
    Intervention Type
    Other
    Intervention Name(s)
    Almonds
    Intervention Description
    Whole raw almonds provided as a mid-morning snack - 0.9g\kg
    Intervention Type
    Other
    Intervention Name(s)
    Cheese Savouries
    Intervention Description
    Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
    Primary Outcome Measure Information:
    Title
    Test Meal Energy Intake
    Description
    Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.
    Time Frame
    3 Weeks
    Secondary Outcome Measure Information:
    Title
    Food Preference
    Description
    Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator. Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008). 8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score. Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome.
    Time Frame
    3 Weeks
    Title
    Appetite Sensations (Hunger)
    Description
    Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator. Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS). Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method. Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention. Higher AUC scores on hunger are interpreted as a worse outcome.
    Time Frame
    3 Weeks
    Title
    24 Hour Energy Intake
    Description
    Measured reductions in total within-day energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart.
    Time Frame
    3 Weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants who have provided written informed consent. Healthy female participants aged 18-55 years. BMI of 18.5 - 30.0 kg/m2. Regular breakfast eaters. Not currently dieting to lose, gain or maintain weight. Non-smokers. Liking/acceptance of the study foods (≥4 on 7-point Likert scale). Exclusion Criteria: Taking medication known to affect appetite within past month and/or during the study. Any known food allergies or food intolerances. Participants who do not regularly eat breakfast. Participants with low liking or acceptance of the study foods. Participants currently dieting to lose, gain or maintain weight. Reported history of or present eating disorder. BMI <18.5 kg/m2 or >30 kg/m2. Vegetarians.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Graham Finlayson, PhD
    Organizational Affiliation
    University of Leeds
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Results to be written up for submission to peer-review scientific journal.
    Citations:
    PubMed Identifier
    21651803
    Citation
    Gibbons C, Caudwell P, Finlayson G, King N, Blundell J. Validation of a new hand-held electronic data capture method for continuous monitoring of subjective appetite sensations. Int J Behav Nutr Phys Act. 2011 Jun 8;8:57. doi: 10.1186/1479-5868-8-57.
    Results Reference
    background
    PubMed Identifier
    17655972
    Citation
    Finlayson G, King N, Blundell J. The role of implicit wanting in relation to explicit liking and wanting for food: implications for appetite control. Appetite. 2008 Jan;50(1):120-7. doi: 10.1016/j.appet.2007.06.007. Epub 2007 Jun 28.
    Results Reference
    background
    PubMed Identifier
    31480245
    Citation
    Hollingworth S, Dalton M, Blundell JE, Finlayson G. Evaluation of the Influence of Raw Almonds on Appetite Control: Satiation, Satiety, Hedonics and Consumer Perceptions. Nutrients. 2019 Aug 30;11(9):2030. doi: 10.3390/nu11092030.
    Results Reference
    derived

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