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

NCT04327245 | Completed DMC

• 1 other identifier: SOCHED
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Insulin Resistance; Hyperinsulinism

Keywords

High-Intensity Sweeteners; Non-Nutritive Sweeteners; Stevia rebaudiana; C-Peptide; Blood Glucose

Outcome Measures

Primary Outcomes (1)

• glycemic response in blood

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

  Three hours

Secondary Outcomes (1)

• C-peptide response in blood

  Three Hours

Other Outcomes (2)

• The analogue visual scale questionnaires (VAS)

  30 minutes

• Through food provided ad libitum (objective appetite)

  30 minutes

Study Arms (3)

Intervention ingest a 5000 mg of D-tagatose

EXPERIMENTAL

Intervention: 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.

Other: Intervention ingest a 5000 mg of D-tagatose

No Intervention: Intervention ingest a water (control group)

NO INTERVENTION

Woman with resistance insulin who ingest a water (control group)

Intervention ingest a 15,3 mg of stevia

EXPERIMENTAL

Intervention: 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.

Other: Intervention ingest a 15,3 mg of stevia

Interventions

Intervention ingest a 5000 mg of D-tagatose OTHER

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 5000 mg of D-tagatose

Intervention ingest a 15,3 mg of stevia OTHER

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)

Intervention ingest a 15,3 mg of stevia

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Sociedad Chilena de Diabetes y Endocrinología (SOCHED): collaborator

Related Publications (1)

• 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.

  PMID: 35623816 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Hyperinsulinism

Interventions

tagatose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant has no knowledge of the intervention assignment
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director

Model Details: 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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: January 15, 2017
• Primary Completion: December 23, 2018
• Study Completion: October 25, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share