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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480582
First Posted: June 24, 2015
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Dr Graham Finlayson, University of Leeds
  Purpose
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.

Condition Intervention
Lack of Satiety Hyperphagia Other: Almonds Other: Cheese Savouries

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control

Further study details as provided by Dr Graham Finlayson, University of Leeds:

Primary Outcome Measures:
  • Test Meal Energy Intake [ Time Frame: 3 Weeks ]
    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 [ Time Frame: 3 Weeks ]

    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) [ Time Frame: 3 Weeks ]

    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 [ Time Frame: 3 Weeks ]
    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.


Enrollment: 42
Study Start Date: June 2015
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Almond, then No Food, then Cheese Savouries
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).
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Experimental: Cheese Savouries then Almond, then No Food
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.
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Experimental: No Food, then Cheese Savouries, then Almond
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).
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Experimental: Cheese Savouries, then No Food, then Almond
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).
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Experimental: Almond, then Cheese Savouries, then No Food
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.
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Experimental: No Food, then Almond, then Cheese Savouries
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).
Other: Almonds
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Other: Cheese Savouries
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480582


Sponsors and Collaborators
University of Leeds
Almond Board of California
Investigators
Principal Investigator: Graham Finlayson, PhD University of Leeds
  More Information

Publications:
Responsible Party: Dr Graham Finlayson, Principal Investigator, University of Leeds
ClinicalTrials.gov Identifier: NCT02480582     History of Changes
Other Study ID Numbers: LDS-2015-ABC
RG.PSYC.102933 ( Other Grant/Funding Number: Almond Board of California )
First Submitted: June 4, 2015
First Posted: June 24, 2015
Results First Submitted: May 31, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results to be written up for submission to peer-review scientific journal.

Additional relevant MeSH terms:
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms