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Insulin ResistanceNCT04327245

To Compare the Effects of Non-nutritive Sweeteners Intake in Woman With Insulin Resistance

A study testing Intervention ingest a 5000 mg of D-tagatose and Intervention ingest a 15,3 mg of stevia in people with Insulin Resistance and Hyperinsulinism, run by University of Chile.

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

ABSTRACT Introduction: There is no current data about the effects of non-nutritive sweeteners (NNS) about important factors, such as the energy intake, appetite and its relationship in people with insulin resistance when tasting sweet. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Insulin Resistance, Hyperinsulinism
What is being tested?
Intervention ingest a 5000 mg of D-tagatose and Intervention ingest a 15,3 mg of stevia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
15 Jan 2017to 25 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Woman with Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2,5
  • Body Mass Index (BMI) between 18.5 to 34.9 kg / m2
  • Stable doses of oral contraceptive
  • cigarette smoking <5 units / day
  • Women on metformin treatment were allowed with the requirement of discontinuation for a period of four weeks prior to study initiation.

Who cannot join

  • sex male
  • pregnant or lactating women
  • women with diseases, conditions or medications that provoke hyperinsulinism or that alter the glucidic metabolism, the postprandial hormonal response, appetite and / or satiety
  • those who carry out moderate to intense physical activity three or more times a week for more than 30 minutes at a time
  • those with the use of vitamin supplements or antioxidants
  • Women with an allergy or aversion to the sweeteners used in the study.

About this study

Official title: Effect of Intake of Stevia and D-tagatose Sweeteners on Glycemia, Peptide C and Appetite-satiety in Women With Insulin Resistance

ABSTRACT

Introduction: There is no current data about the effects of non-nutritive sweeteners (NNS) about important factors, such as the energy intake, appetite and its relationship in people with insulin resistance when tasting sweet. It is highly relevant to compare the effects of NNS intake, such as, stevia (steviol glycosides) and D-tagatose, previous to a 75-gram oral glucose tolerance test (OGTT) on glycaemic and C-peptide responses in women with insulin resistance.

Read more

Objective: To compare the effects of non-nutritive sweeteners intake: stevia (steviol glyco-sides) and sucralose previous to OGTT on appetite, glycemia and C-peptide plasmatic concentrations in women with insulin resistance.

Methods: Thirty-three women with T2DM were studied in 3 different moments and they received 3 treatments: pre-load of water or D-tagatose or stevia and then offered to consume a 75-gram oral glucose tolerance test. Blood samples were obtained to measure the dependent variables, glycemic at times -10, 0, 30, 60, 90, 120 and 180 minutes and C-peptide at times -10, 30, 90, 120 and 180 minutes. The analogue visual scale questionnaires (VAS) was conducted every 30 minutes in order to obtain the results of the depend variables: appetite and wish of specific type of food in a subjective way; appetite, satiety, relax, wish to eat any food, craving for something sweet, craving for something salty, something tasty, something fatty. Through food provided ad libi-tum (objective appetite), were obtained the results of: energy, carbohydrates, proteins and lipid intakes. The statistical analysis applied included the Shapiro-Wilk's Normality test, repeated measures ANOVA to assess differences among treatments, Friedman's test followed by Wilcoxon test corrected by Bonferroni as needed. The degree of association between variables was conducted using the Pearson's or Spearman's correlation coefficient tests, as requested. A probability value p <0.05 was considered significant.

Read the detailed description

Protocol The experimental design was developed 3 times. Each intervention was performed separately for a minimum period of 7 days out and a maximum of 14 days, depending on the availability of the experimental subjects. Cross treatment design (crossover) each women serves as its own control The first intervention corresponded to the control group, in order to maintain the ignorance of the type of sweetener they were receiving, between day 7 or maximum 14 days post-intervention the order of the test of the NNS was reversed. Therefore, during the second or third intervention they were given to drink water with D-tagatose or stevia respectively. For each intervention a check list was followed.

Subjects were asked to maintain their normal diet between study days and abstain from strenuous exercise and alcohol intake for 24 hours before each evaluation. The subjects attended with an 8-hour fast, without having ingested medication, to the sampling room of the Pharmacy Faculty, University of Valparaís. The study was only begun if they had a capillary glycemia <100%, measured through a glucometer.

Then, they were asked to answer the analogue visual scale (VAS) questionnaire and an intravenous catheter was installed in the antecubital vein to take the blood samples at "time -10". Immediately, they were given to drink 60 ml of water or 60 ml of water with 5000 mg of D-tagatose or an equivalent volume with 15,3 mg of stevia (steviol glycosides), which they had to consume in less than 2 minutes.

After 10 minutes, at "time 0" immediately after the second blood sample, the individuals consumed a 75-gram oral glucose tolerance test (OGTT).

The following blood samples were taken at times 30, 60, 90, 120 and 180 minutes after "time 0". In total, 28 ml of blood was extracted, in each time the glycemia and C-peptide were determined (4 ml was taken at a time).

In addition, VAS questionnaires were applied every 30 minutes, from "time -10" to 180 minutes for appetite determinations.

After completing the extraction of blood samples at 180 minutes and removing the intravenous catheter, the subjects were offered a meal for 30 minutes, which consisted of a variety of foods of high acceptability, previously weighed and fractionated.

Statistic analysis The normal distribution of the variables was determined by the Shapiro-Wilk test. The natural logarithm was applied to the parameters without normal distribution. The variables were expressed as mean ± standard deviation or median plus interquartile interval (Q1-Q3). The statistical significance between the differences in plasma glucose concentrations, area under the curve (AUC) of glycaemia, energy intake and macronutrients by treatment (preload water, D-tagatose and stevia), was evaluated through Anova of repeated samples . To analyze the differences between plasma concentrations and AUC of C-peptide and glycaemia per treatment (preload water, D-tagatose and stevia), Friedman's test was used, followed by Wilcoxon and adjusted by Bonferroni.

To identify the relationships between glycemic responses and intake of food at will (energy intake and macronutrients by treatment, preload water, D-tagatose and stevia), the Pearson correlation factor was used, in contrast to C-peptide response and the visual analogue scale (VAS) and food intake at will per treatment Spearman's correlation factor was used.

The statistical analysis was performed with the SPSS 20.0 computer program (SPSS Inc., Chicago Illinois). A p <0.05 was considered statistically significant for all the analyzes.

Being tested
Intervention ingest a 5000 mg of D-tagatose, Intervention ingest a 15,3 mg of stevia
Keywords
High-Intensity Sweeteners, Non-Nutritive Sweeteners, Stevia rebaudiana, C-Peptide, Blood Glucose
Medical subject headings
Insulin Resistance, Hyperinsulinism

What participants receive

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

  • Intervention ingest a 5000 mg of D-tagatoseOther

    Woman with resistance insulin who ingest a 5000 mg of D-tagatose. D-tagatose is a sweetener of natural origin, low in calories (1.5 kcal / g) and with a sweetness power of 0.9.

    About 20 to 25% of the ingested D-tagatose is absorbed and metabolized in the liver, the rest is fermented by the microbiota producing short chain fatty acids.

  • Intervention ingest a 15,3 mg of steviaOther

    Woman with resistance insulin who ingest a 15,3 mg of stevia (steviol glycosides). The word "stevia" refers to the whole plant of Stevia rebaudiana Bertoni (SRB), only some of the components of the stevia leaf are sweet. Steviol glycosides are up to 300 times sweeter than sucrose, do not provide calories and can be used as a substitute for sucrose or as a non-nutritive sweetener alternative. Your allowable daily intake is 4 mg / kg / body weight (expressed as steviol)

Study groups in NCT04327245
Study groupRoleWhat they receive
Intervention ingest a 5000 mg of D-tagatoseExperimentalIntervention: Women with resistance insulin who ingest a 5000 mg of D-tagatose. D-tagatose is a sweetener of natural origin, low in calories (1.5 kcal / g) and with a sweetness power of 0.9.e.
Receives: Other: Intervention ingest a 5000 mg of D-tagatose
No Intervention: Intervention ingest a water (control group)No interventionWoman with resistance insulin who ingest a water (control group)
Intervention ingest a 15,3 mg of steviaExperimentalIntervention: Woman with resistance insulin who ingest a 15,3 mg of stevia (steviol glycosides). The word "stevia" refers to the whole plant of Stevia rebaudiana Bertoni (SRB), only some of the components of the stevia leaf are sweet.
Receives: Other: Intervention ingest a 15,3 mg of stevia

What is being measured

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

  1. glycemic response in blood

    Area under the curve was built for each subjects after steviol or D-tagatose or water intake.

    Measured: Three hours

Secondary outcomes (1)
  1. C-peptide response in blood

    Area under the curve was built for each subjects after steviol or D-tagatose or water intake.

    Measured: Three Hours

Timeline

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

  1. First posted31 Mar 2020
  2. Study start15 Jan 2017
  3. Primary completion23 Dec 2018
  4. Study completion25 Oct 2019

Resources

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
Screening
Allocation
Randomised
Intervention model
Crossover
Model description
The experimental design was developed 3 times. Each intervention was performed separately for a minimum period of 7 days out and a maximum of 14 days, depending on the availability of the experimental subjects. Cross treatment design (crossover) each women serves as its own control The first intervention corresponded to the control group, in order to maintain the ignorance of the type of sweetener they were receiving, between day 7 or maximum 14 days post-intervention the order of the test of the NNS was reversed. Therefore, during the second or third intervention they were given to drink water with D-tagatose or stevia respectively
Masking
Single blind
Who is masked
Participant
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327245
Sponsor's protocol ID
SOCHED
Status last verified
Mar 2020
First submitted
26 Mar 2020
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sambra V, Vicuna IA, Priken KM, Luna SL, Allendes DA, Godoy PM, Novik V, Vega CA. Acute responses of stevia and d-tagatose intake on metabolic parameters and appetite/satiety in insulin resistance. Clin Nutr ESPEN. 2022 Jun;49:217-224. doi: 10.1016/j.clnesp.2022.04.018. Epub 2022 Apr 22.

    PubMed 35623816

Questions about this trial

What is this clinical trial studying?

A study testing Intervention ingest a 5000 mg of D-tagatose and Intervention ingest a 15,3 mg of stevia in people with Insulin Resistance and Hyperinsulinism, run by University of Chile.

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 5 inclusion and 6 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 31 Mar 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

glycemic response in blood (time frame: Three hours). 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 NCT04327245, which also lists 1 linked publication.

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 31 Mar 2020.

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