ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001384145

Ethics application status

Approved

Date submitted

27/08/2019

Date registered

10/10/2019

Date last updated

5/03/2021

Date data sharing statement initially provided

10/10/2019

Date results provided

5/03/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of prior consumption of gymnema sylvestre on desire for sugar-sweetened products in adults

Scientific title

Effect of prior consumption of gymnema sylvestre on desire for sugar-sweetened products in adults

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1239-2873

Trial acronym

Linked study record

Health condition

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

Sugar intake

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Upon arrival to the sensory laboratory, participants will be provided one muesli bar (standard serve) each to reduce hunger (45 min prior to testing). During the 45 minutes prior to the sensory testing, participants will then complete a Food Frequency Questionnaire, body composition measures and demographic questionnaire.

Participants will record their hunger and desire for sugar-sweetened product (confectionery). They will then consume a small standardised serving (13g) of their favourite confectionary (from 6 popular brands; which will be provided by the research team), and we will record pleasantness ratings as well as desire for consuming a second serving.

They will then randomly be given the tablet (by the research assistant) containing gymnema sylvestre (4mg per tablet) or isocaloric placebo, and asked to ingest the product. Participants and research assistants will be blinded to the tablets provided.

Participants will then rate their desire for another serving (i.e. 13 g) of their preferred confectionary and will be offered up to five servings, which will be given one after the other (after consumption, they will be given 1 minute before selecting a subsequent serving). They will be asked to rate desire for consuming another serving and pleasantness of the confectionary after each serving has been consumed.

If an offering is accepted, it will be consumed and perceptual ratings will be recorded. If an offering is declined, testing and data collection for that participant will end.

This is a crossover trial; there will be a minimum of three days between trials (the effects of one gymnema-containing tablet last between 30-60 min).

This is an acute trial, so participants will not need to record consumption/adherence.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Placebo mint will be used (contains exactly the same ingredients apart from gymnema sylvestre)

Control group

Placebo

Outcomes

Primary outcome [1]

Number of servings of sugar-sweetened confectionary consumed post ingestion of gymnema sylsvestre-containing mint/tablet.

The research assistant will count how many servings are consumed by the participant at each visit (and verify consumption by the empty confectionary wrapper).

Timepoint [1]

Acute (within 30-40 min of consuming the mint/tablet

Secondary outcome [1]

Perceived hunger level

Timepoint [1]

Assessed using Likert scale within 30-40 min of consuming the mint/tablet containing gymnema sylvestre.

Secondary outcome [2]

Effect of body fat percentage on changes to amount of confectionery eaten and sensory ratings, following consumption of gymnema sylvestre-containing mint/tablet

Body fat (%) will be assessed using bio-electrical impedance analysis (BIA)

Timepoint [2]

Will be assessed using bio-electrical impedance analysis (BIA) prior to consuming gymnema-containing mint/tablet

Secondary outcome [3]

Effect of 'super-tasting' ability on changes to amount of confectionery eaten and sensory ratings, following consumption of gymnema sylvestre-containing mint/tablet

Participants’ taster status will be determined using propylthiouracil (PROP) solution. Participants will be asked to taste this solution and indicate the perceived bitterness intensity. This will be used to classify subjects as either super-tasters, tasters or non-tasters. This information will be useful in interpreting the sensory data based on individual differences in taste sensitivity.

Timepoint [3]

Will be assessed using PROP prior to consuming gymnema-containing mint/tablet

Secondary outcome [4]

Effect of having a 'sweet tooth' (assessed using food frequency questionnaire; composite analysis) on changes to amount of confectionery eaten and sensory ratings, following consumption of gymnema sylvestre-containing mint/tablet

Timepoint [4]

A food frequency questionnaire will be used (composite analysis) to assess 'sweet tooth' prior to consuming gymnema-containing mint/tablet

Secondary outcome [5]

Desire to eat another sugar-sweetened product (confectionery)

Timepoint [5]

Will be assessed using a Likert scale within 30-40 minutes of consuming gymnema-containing mint/tablet

Secondary outcome [6]

Pleasantness ratings of confectionary

Timepoint [6]

Will be assessed using a Likert scale within 30-40 minutes of consuming gymnema-containing mint/tablet

Eligibility

Key inclusion criteria

Healthy adults aged 18-45 years old
Non-smoking
Non-diabetic
English-speaking

Minimum age

18 Years

Maximum age

45 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Known allergies to gymnema sylvestre

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

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

All participants will be given the control/placebo treatment first trial; they will then have the experimental condition in the second trial

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

Non-randomized; all will take part in control trial first (followed by experiential condition in second trial)

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

Statistical analyses will be completed using the Statistical Package for the Social Sciences (SPSS, Chicago, IL). All data will be inspected visually and statistically for normality. Normally distributed data will be described using mean ± SD and non-normally distributed data using median and ranges. Two-way analysis of variance (ANOVA) will be used to determine the difference between conditions at each time point evaluated. A suitable post-hoc test (Holm-Bonferroni adjusted paired t-test) will be used to ascertain differences between time points. Pearson’s correlation will be used to examine relationships between outcome measures. P<0.05 will be considered indicative of statistical significance. Furthermore, effect sizes (Cohen’s d) will be calculated (where applicable) to show practical significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/10/2019

Date of last participant enrolment

Anticipated

29/11/2019

Actual

10/10/2019

Date of last data collection

Anticipated

6/12/2019

Actual

10/10/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

AUCKLAND

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Nu Brands Ltd

Address [1]

936 N Laurel Avenue
Los Angeles CA 90046
USA

Country [1]

United States of America

Primary sponsor type

University

Name

Massey University

Address

Private Bag 11222
Palmerston North 4442

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Massey University Human Ethics Committee

Ethics committee address [1]

Massey University
Private Bag 11222
Palmerston North 4442

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

29/07/2019

Approval date [1]

20/09/2019

Ethics approval number [1]

MUHEC SOA 19/47

Summary

Brief summary

Gymnema sylvestre (gymnema) is a plant-derived sweetness inhibitor which impairs one’s ability to taste sugar by temporarily blocking sweet receptors on the tongue. It is therefore a taste modulator which interferes with the ability of sucrose to activate the sweet receptors on the tongue leading to a decrease in sweetness perception without affecting the other basic tastes. This effect is reversible and lasts between 30-60 minutes. 
Gymnema is popular not only due to its anti-saccharine effect, but also because of its hypoglycemic effect and hence its use in diabetes management. To demonstrate its sucrose perception suppressing ability, tea is prepared from gymnema leaves and panellists asked to swish and amount in their mouths prior to tasting foods and sweet products (Noel et al. 2017; Hudson et al., 2018). Utilization of this plant is expanding from Ayurvedic medicine to applications in food product development (Perera and Pavitha, 2017). There is some uncertainty about observing this kind of effect (Shroeder and Flannery-Schroeder, 2005) when the leaves are processed as the case will be if the active ingredient is used in the formulation of a tablet. There is therefore the need to determine if the doses of the active ingredient used in the tablets reduces perception of sweetness. But, most importantly for this project, whether this decrease in sugar perception leads to an aversion to sugar-sweetened products. Therefore, the aim of the study is to determine whether prior consumption of gymnema is associated with a decrease in perceived hunger ratings, desire for sugar-sweetened products and pleasantness ratings of sugar-sweetened products.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof AJMOL ALI

Address

School of sport, Exercise and Nutrition
Massey University
Private Bag 102904
North Shore, Auckland

Country

New Zealand

Phone

+64 9 213 6414

Fax

a.ali@massey.ac.nz

Contact person for public queries

Name

AJMOL ALI

Address

School of sport, Exercise and Nutrition
Massey University
Private Bag 102904
North Shore, Auckland

Country

New Zealand

Phone

+64 9 213 6414

Fax

a.ali@massey.ac.nz

Contact person for scientific queries

Name

AJMOL ALI

Address

School of sport, Exercise and Nutrition
Massey University
Private Bag 102904
North Shore, Auckland

Country

New Zealand

Phone

+64 9 213 6414

Fax

a.ali@massey.ac.nz

Data sharing statement

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

No/undecided IPD sharing reason/comment

Only mean and standard deviation data will be available (via the subsequent publications)

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	Consuming gymnema sylvestre reduces the desire for high-sugar sweet foods.	2020	https://dx.doi.org/10.3390/nu12041046

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

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