Trial Review

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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] 297129 0
None
Universal Trial Number (UTN)
U1111-1224-6712
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
obesity 311155 0
Condition category
Condition code
Diet and Nutrition 309779 309779 0 0
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] 313511 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules containing canola oil for within group comparison.
Control group
Placebo

Outcomes
Primary outcome [1] 318911 0
Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Hunger
Timepoint [1] 318911 0
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] 319486 0
Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Fullness
Timepoint [2] 319486 0
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] 319487 0
Changes in subjective measures of appetite as determined by Visual Analogue Scale (VAS) for Satisfaction
Timepoint [3] 319487 0
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] 366389 0
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] 366389 0
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] 366390 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Thirst
Timepoint [2] 366390 0
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] 366391 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Energy
Timepoint [3] 366391 0
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] 366392 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Nausea
Timepoint [4] 366392 0
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] 368389 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Sickness
Timepoint [5] 368389 0
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] 368390 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Vomiting
Timepoint [6] 368390 0
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] 368391 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Bloating
Timepoint [7] 368391 0
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] 368392 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Crap/Discomfort
Timepoint [8] 368392 0
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] 368393 0
Changes in subjective measures of possible side-effects as determined by Visual Analogue Scale (VAS) for Heart Burn
Timepoint [9] 368393 0
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] 368394 0
Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Difficulty in maintaining fast,
Timepoint [10] 368394 0
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] 368395 0
Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Prospective thoughts of future compliance to a fast,
Timepoint [11] 368395 0
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] 368396 0
Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Current thought of compliance to Fast,
Timepoint [12] 368396 0
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] 368397 0
Changes in subjective measures of compliance as determined by Visual Analogue Scale (VAS) for Fast-Related Side effects.
Timepoint [13] 368397 0
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] 368398 0
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] 368398 0
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] 368399 0
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] 368399 0
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] 21248 0
New Zealand
State/province [1] 21248 0
Palmerston North

Funding & Sponsors
Funding source category [1] 301690 0
Other
Name [1] 301690 0
The New Zealand Institute for Plant & Food Research Limited
Country [1] 301690 0
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] 301410 0
None
Name [1] 301410 0
Address [1] 301410 0
Country [1] 301410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302410 0
Southern Health and Disability ethics committee
Ethics committee address [1] 302410 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington, 6011
Ethics committee country [1] 302410 0
New Zealand
Date submitted for ethics approval [1] 302410 0
29/11/2018
Approval date [1] 302410 0
20/12/2018
Ethics approval number [1] 302410 0
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 90146 0
Dr Edward Walker
Address 90146 0
The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 90146 0
New Zealand
Phone 90146 0
+64 9 925 7050
Fax 90146 0
Email 90146 0
[email protected]
Contact person for public queries
Name 90147 0
Dr Edward Walker
Address 90147 0
The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 90147 0
New Zealand
Phone 90147 0
+64 9 925 7050
Fax 90147 0
Email 90147 0
[email protected]
Contact person for scientific queries
Name 90148 0
Dr Edward Walker
Address 90148 0
The New Zealand Institute for Plant & Food Research.
Private Bag 92169, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 90148 0
New Zealand
Phone 90148 0
+64 9 925 7050
Fax 90148 0
Email 90148 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseNew Zealand bitter hops extract reduces hunger during a 24 h water only fast.2019https://dx.doi.org/10.3390/nu11112754
N.B. These documents automatically identified may not have been verified by the study sponsor.