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

January 25, 2017 updated by: Dr Graham Finlayson, University of Leeds
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.

Study Overview

Status

Completed

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).

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
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.
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
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).
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
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).
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
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.
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
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).
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

3 Weeks
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.

3 Weeks
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.
3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Graham Finlayson, PhD, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDS-2015-ABC
  • RG.PSYC.102933 (Other Grant/Funding Number: Almond Board of California)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results to be written up for submission to peer-review scientific journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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