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Trial registered on ANZCTR

Registration number

ACTRN12619000454178

Ethics application status

Approved

Date submitted

7/03/2019

Date registered

19/03/2019

Date last updated

19/03/2019

Date data sharing statement initially provided

19/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of a hops extract on hunger and appetite in healthy men during a 24 fast.

Scientific title

Determining the efficacy of a hops-based appetite suppressant on hunger, appetite and subsequent rebound eating in healthy men undergoing a 24h fast.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1224-6712

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Subjects will consume, in randomized, double-blind fashion (cross-over design), gastric digestion resistant capsules (DRCaps, Capsugel) containing i) 500mg (2x250mg) super critical CO2 extract of hops flower (Amarasate), ii) 200mg (2x100mg) Amarasate, or iii) matching placebo (control). Each subject will receive half the total treatment twice during a given study day (at 10:00 and 14:00), and treatments i, ii, and iii will occur on separate occasions. Study visits will be separated by at least 7 days. During study laboratory visits, the lead researchers will be present to closely monitor adherence to study protocol. At 6pm on the evening prior to study day, participants will be instructed to not consume and food or drinks other than water, with compliance determined by participant self-report. On each study day, subjects will being the laboratory based assessments at 10:00 hr (t=0 min) and will complete appetite-related VAS and food cravings questionnaires throughout to study day. Immediately following the first questionnaire, subjects will ingest the first treatment capsules of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water, within 2 mins. VAS questionnaires will be collected 30-min intervals from 10:00 (t=0 min) to 18:00h (t=480min) of the study day. Food craving questions will be asked at 10:00h, 12:00h, 14:00h, 16:00h and 18:00h. At 14:00h subjects will be giving the second treatment capsule (matched to the one given at 10:00h) of either (i) 250mg Amarasate (ii), 100mg Amarasate or (iii) control, with 250 ml of water and to be consumed within 2 mins. VAS and food craving questionnaires continue as described above. At 18:00h, subjects will be allowed to leave the laboratory.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo capsules containing canola oil for within group comparison.

Control group

Placebo

Outcomes

Primary outcome [1]

Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Hunger

Timepoint [1]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Primary outcome [2]

Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Fullness

Timepoint [2]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Primary outcome [3]

Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Satisfaction

Timepoint [3]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [1]

Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Thoughts of Food

Note: This is a primary outcome.

Timepoint [1]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [2]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Thirst

Timepoint [2]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [3]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Energy

Timepoint [3]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [4]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Nausea

Timepoint [4]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [5]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Sickness

Timepoint [5]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [6]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Vomiting

Timepoint [6]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [7]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Bloating

Timepoint [7]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [8]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Crap/Discomfort

Timepoint [8]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [9]

Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Heart Burn

Timepoint [9]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [10]

Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Difficulty in maintaining fast,

Timepoint [10]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [11]

Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Prospective thoughts of future compliance to a fast,

Timepoint [11]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [12]

Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Current thought of compliance to Fast,

Timepoint [12]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [13]

Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Fast-Related Side effects.

Timepoint [13]

VAS measures will be taken through the 16h to 24h fasting period ever 30 mins. Specifically at 1000h (t=0), 1030h, 1100h, 1130h, 1200h, 1230h, 1300h, 1330h 1400h, 1430h, 1500h, 1530h, 1600h, 1630h, 1700h, 1730h and 1800h (t=480)

Secondary outcome [14]

Food Cravings as determined by open ended questions: "What food are you thinking of right now?", and "If you could, what would you eat and why?"
Assessments will be based on changes in macronutrient make-up, energy density, classification of food type and total energy of foods thought of/desired. "Why" food is desired is will be assessed based on primary descriptor used for choice justification.

Timepoint [14]

Measures will be taken through the 16h to 24h fasting period ever 120 mins. Specifically at 1000h (t=0), 1200h, 1400h, 1600h and 1800h (t=480)

Secondary outcome [15]

Rebound energy intake, As assessed by comparing food diaries taken 3 days before the 24h fast day to food diary completed for the 24h post fast.

Timepoint [15]

Food diaries will be taken for 3 days (72h) prior to the start of each 24h fast trial day and for 1 day (24h) after the completion of each of the 24h fast trial days.
Specifically, pre-fast diaries will be started at 1800h 3 days prior to the commencement of the fast and finish 72 hours later at 1800h (0h of fast, t=-960). Post-fast diaries will be started immediately post-fast at 1800h (t=480) and finish 24 hours later at 1800h the following day.

Eligibility

Key inclusion criteria

Males
Aged 18-55 years
BMI 20-25kg/m2
Normal gross gastrointestinal tract anatomy, as ascertained by self-report
Generally healthy, as ascertained by self-report
Regularly eat breakfast and lunch and dinner, as determined by self-reporting.

Minimum age

18 Years

Maximum age

55 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Any medical conditions or medications known to affect appetite -related parameters, including depression, diabetes and glucose intolerance or supplements that regulate appetite.
Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months
Smoker or ex-smoker who quit within the last 6 months
Hypersensitivities or allergies to any ingredients included in the study capsules
Dislike and/or unwilling to consume items listed as study foods (i.e inability to swallow capsules)
Unwilling/unable to comply with study protocol
Conditions effecting the gastrointestinal tract
Abnormal hunger and meal patterns, as ascertained by self-assessment
Any medical condition that may affect ability to safely participate in a 24h fast.
Current intake of any illegal substance(s)
High performance athletes.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligible volunteers are assigned a subject number and randomised onto a treatment visit schedule based on a Latin square design balanced for order of presentation and carry-over effect. Treatments will be assigned a code and aliquoted into sealed/opaque containers with only the treatment code visible. The treatment code will be held by 2 scientist who are not responsible for treatment dispensing or data collection. The unblinded scientist(s) are responsible for allocating a random treatment position to the volunteers and preparing the study treatments for dispensing.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation plan for assigning volunteers onto the Latin square design is generated using a randomization plan generator available at https://www.randomizer.org/

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data on demographic and anthropometric characteristics will be summarized using descriptive statistics. VAS data throughout the experiment will be analysed using repeated measures Linear Mixed Model ANOVA with appropriate covariance structure (SAS: PROC MIXED, SAS version 9.4, SAS Institute Inc, Cary, NC, 2013). Time to return to pre-treatment baseline for VAS hunger and fullness will also be analysed using the Friedman nonparametric procedure (SPSS version 16.0, SPSS Inc, Chicago, Il, USA, 2007), ie to assess the possibility of ‘suppression of hunger’ and ‘fuller for longer’ across treatments. Where the repeated measures Linear Mixed Model ANOVA is significant, Tukey’s post hoc analysis will be used for comparisons between conditions.

A power analysis was performed to provide estimates of variance components using data from Deloose et al 2017 where an intra-gastric gavage of the exceedingly bitter denatonium was given and VAS or hunger and fullness were measured. Calculations were done on the primary end point of VAS for changes in hunger. In the current study it is anticipated that 24-30 participants will be required to complete the 3 treatment days. The model based upon an estimated error variance taken from Deloose et al 2017 and estimated, using power of 0.8 suggests that the number of subjects required is estimated to fall between 24-30 subjects. Given the potential for participants to withdraw from the study, recruiting 30 people will allow for 80% power even after potential withdraws.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

25/03/2019

Actual

Date of last participant enrolment

Anticipated

1/04/2019

Actual

Date of last data collection

Anticipated

19/04/2019

Actual

Sample size

Target

30

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Palmerston North

Funding & Sponsors

Funding source category [1]

Other

Name [1]

The New Zealand Institute for Plant & Food Research Limited

Address [1]

Plant & Food Research
120 Mt Albert Road,
Sandringham,
Auckland, 1025,
New Zealand

Country [1]

New Zealand

Primary sponsor type

Other

Name

The New Zealand Institute for Plant & Food Research Limited

Address

Plant & Food Research
120 Mt Albert Road,
Sandringham,
Auckland, 1025,
New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability ethics committee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington, 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

29/11/2018

Approval date [1]

20/12/2018

Ethics approval number [1]

18/STH/267

Summary

Brief summary

Obesity is associated with increased risk of a number of diseases including diabetes, heart disease, hypertension, and cancer. Traditional lifestyle treatments for obesity have focused on diet as both a preventative and treatment option and although diet has proven to be effective, recent discoveries have suggested that an intermittent fasting diet regime potentially offers greater health benefits when compared to classically prescribed diets.

Intermittent fasting has been shown to be effective for the reduction of body weight, to decrease pro-inflammatory proteins and blood glucose levels, reduce heart rate, and to reduce blood pressure and insulin levels. However, intermittent fasting results in increased feeling of hunger during the fasting period (specifically during the 16-24h period) that may affect compliance to the intermittent fasting diet regime, and results in a certain degree of rebound eating post fast. The addition of an appetite suppressant to an intermittent fasting diet may reduce increased hunger levels and improve compliance. 

We have recently demonstrated that the gastrointestinal delivery of a highly bitter, non-nutritive, plant extract can stimulate the release of appetite-suppressing gut satiety hormones in lean healthy men. We hypothesise that consumption of this extract will also reduce subjective rating of hunger and improve compliance during hours 16-24h of a complete 24h fasting day, and reduce rebound eating post fast in healthy men. To test this hypothesis 30 healthy men will be recruited into a randomised, double-blind, placebo controlled, cross-over study designed to investigate the acute effect of a twice daily (10am, 2pm) high (2 x 250 mg) or low (2 x 100 mg) dose of the extract verses a placebo (2 x vehicle control) on subjective ratings of appetite, compliance and rebound eating and gastrointestinal side effects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Edward Walker

Address

The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand

Country

New Zealand

Phone

+64 9 925 7050

Fax

Email

edward.walker@plantandfood.co.nz

Contact person for public queries

Name

Edward Walker

Address

The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand

Country

New Zealand

Phone

+64 9 925 7050

Fax

Email

edward.walker@plantandfood.co.nz

Contact person for scientific queries

Name

Edward Walker

Address

The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand

Country

New Zealand

Phone

+64 9 925 7050

Fax

Email

edward.walker@plantandfood.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No

No/undecided IPD sharing reason/comment

This is for two reasons. 1 That our ethical application requires all data generated will only be used only for this study. However, if required, additional consent can be sought to allow other studies to access this data. 2. There may be commercial restrictions on this data.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	New Zealand bitter hops extract reduces hunger during a 24 h water only fast.	2019	https://dx.doi.org/10.3390/nu11112754

N.B. These documents automatically identified may not have been verified by the study sponsor.