Lack of SatietyNCT02480582

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

A study testing Almonds and Cheese Savouries in people with Lack of Satiety and Hyperphagia, run by University of Leeds.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Lack of Satiety, Hyperphagia
What is being tested?: Almonds and Cheese Savouries
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Jun 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

About this study

Read the 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).

Conditions: Lack of Satiety, Hyperphagia
Being tested: Almonds, Cheese Savouries
Medical subject headings: Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlmondsOther
Whole raw almonds provided as a mid-morning snack - 0.9g\kg
Cheese SavouriesOther
Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg

Study groups in NCT02480582
Study group	Role	What they receive
Almond, then No Food, then Cheese Savouries	Experimental	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). Receives: Other: Almonds; Other: Cheese Savouries
Cheese Savouries then Almond, then No Food	Experimental	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. Receives: Other: Almonds; Other: Cheese Savouries
No Food, then Cheese Savouries, then Almond	Experimental	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). Receives: Other: Almonds; Other: Cheese Savouries
Cheese Savouries, then No Food, then Almond	Experimental	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). Receives: Other: Almonds; Other: Cheese Savouries
Almond, then Cheese Savouries, then No Food	Experimental	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. Receives: Other: Almonds; Other: Cheese Savouries
No Food, then Almond, then Cheese Savouries	Experimental	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). Receives: Other: Almonds; Other: Cheese Savouries

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 Weeks

Secondary outcomes (3)

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.
Measured: 3 Weeks
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.
Measured: 3 Weeks
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.
Measured: 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Dec 2015

First posted24 Jun 2015 (estimated)
Study startJun 2015
Primary completionNov 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lack of SatietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02480582
Sponsor's protocol ID: LDS-2015-ABC
Other IDs: RG.PSYC.102933
Status last verified: Jan 2017
First submitted: 4 Jun 2015
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Results to be written up for submission to peer-review scientific journal.

Publications

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.
PubMed 21651803
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.
PubMed 17655972
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.
PubMed 31480245

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control
ClinicalTrials.gov ID: NCT02480582
Acronym / sponsor ID: LDS-2015-ABC
Conditions: Lack of Satiety, Hyperphagia
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of LeedsUniversity, hospital or other
Collaborators: Almond Board of California
Study start: Jun 2015
Primary completion: Nov 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 24 Jun 2015 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Almond, then No Food, then Cheese Savouries	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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).
Cheese Savouries then Almond, then No Food	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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.
No Food, then Cheese Savouries, then Almond	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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).
Cheese Savouries, then No Food, then Almond	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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).
Almond, then Cheese Savouries, then No Food	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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.
No Food, then Almond, then Cheese Savouries	Experimental	Other: Almonds, Other: Cheese SavouriesParticipants 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).

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlmondsWhole raw almonds provided as a mid-morning snack - 0.9g\kg	Other	Almond, then Cheese Savouries, then No Food, Almond, then No Food, then Cheese Savouries, Cheese Savouries then Almond, then No Food, Cheese Savouries, then No Food, then Almond, No Food, then Almond, then Cheese Savouries, No Food, then Cheese Savouries, then Almond
Cheese SavouriesCheese savoury crackers provided as a mid-morning snack - 0.9g/kg	Other	Almond, then Cheese Savouries, then No Food, Almond, then No Food, then Cheese Savouries, Cheese Savouries then Almond, then No Food, Cheese Savouries, then No Food, then Almond, No Food, then Almond, then Cheese Savouries, No Food, then Cheese Savouries, then Almond

Primary outcome

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 secondary outcomes

Food Preference
Time frame: 3 Weeks
Appetite Sensations (Hunger)
Time frame: 3 Weeks
24 Hour Energy Intake
Time frame: 3 Weeks

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Almond, Then No Food, Then Cheese Savouries	7	7
Cheese Savouries Then Almond, Then No Food	7	7
No Food, Then Cheese Savouries, Then Almond	7	7
Cheese Savouries, Then No Food, Then Almond	7	7
Almond, Then Cheese Savouries, Then No Food	7	7
No Food, Then Almond, Then Cheese Savouries	7	7

Primary outcome: Test Meal Energy Intake

Time frame: 3 Weeks. Mean (Standard Deviation). Unit: kcal

Measure	Almonds n = 42	Cheese Savouries n = 42	No Food n = 42
Value	1007.3 (299.1)	1019.6 (345.6)	1143.4 (347.4)

Almonds vs Cheese Savouries vs No Food: p <0.01, ANOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months (June 15 - November 15). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Almond, Then No Food, Then Cheese Savouries	0 of 7 (0%)	0 of 7 (0%)	Not reported
Cheese Savouries Then Almond, Then No Food	0 of 7 (0%)	0 of 7 (0%)	Not reported
No Food, Then Cheese Savouries, Then Almond	0 of 7 (0%)	0 of 7 (0%)	Not reported
Cheese Savouries, Then No Food, Then Almond	0 of 7 (0%)	0 of 7 (0%)	Not reported
Almond, Then Cheese Savouries, Then No Food	0 of 7 (0%)	0 of 7 (0%)	Not reported
No Food, Then Almond, Then Cheese Savouries	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21651803Gibbons 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.
Background: PubMed 17655972Finlayson 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.
Derived from this study: PubMed 31480245Hollingworth 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.
Individual participant dataSharing planned: Yes. Results to be written up for submission to peer-review scientific journal.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Graham Finlayson, PhD principal investigator

University of Leeds

Questions about this trial

What is this clinical trial studying?

A study testing Almonds and Cheese Savouries in people with Lack of Satiety and Hyperphagia, run by University of Leeds.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test Meal Energy Intake (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480582, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.