Physiological Effects of Stevia Consumption in Humans

NCT03993418 | Completed

• 1 other identifier: 4812
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether long-term consumption of the low calorie sweetener stevia affects glucose tolerance in healthy participants. With regard to this aim, we will recruit 2 study groups, the stevia group where participants will be required to add stevia drops twice daily in their habitual drinks and the control group where participants will be asked not to change anything in their diet and lifestyle.

Conditions

Glucose Intolerance; Obesity

Outcome Measures

Primary Outcomes (1)

• Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC)

  blood glucose levels will be measured at baseline (0) and at 15, 30, 45, 60, 90 and 120 min after the consumption of a 75 g glucose load and iAUC will be calculated

  Week 0 and week 12

Secondary Outcomes (6)

• Change in body weight

  Week 0, visit week 6 and week 12

• Change in dietary intake

  Week 0, visit week 6 and week 12

• Change in waist circumference

  Week 0, visit week 6 and week 12

• Change in appetite

  Week 0 and week 12

• Change in fasting blood glucose

  Week 0 and week 12

Other Outcomes (6)

• Physical activity

  Week 0, visit week 6 and week 12

• Physical activity

  Week 0, week 6, week 12

• Blood pressure

  Week 0, visit week 6 and week 12

Study Arms (2)

Stevia arm

EXPERIMENTAL

stevia drops

Dietary Supplement: stevia

Control arm

NO INTERVENTION

No change in diet

Interventions

stevia DIETARY_SUPPLEMENT

This arm will be required to consume 5 stevia drops twice daily in habitual drinks

Stevia arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years
• BMI 18.5-25 kg/m2
• No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
• DEBQ for restraint eating ≤ 3
• Healthy - general good health
• Not taking medications that affect metabolism or appetite (i.e. thiazide diuretics, glucocorticoids or beta blockers)
• Stable weight, ≤ 5 kg last 12 months
• Fasting blood glucose ≤6.0 mmol/L
• Willing to comply with the study protocol
• No self-reported food allergy or intolerance to foods supplied during the study
• The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• The participant is able to read, comprehend and record information written in English.
• A signed and dated written informed consent is obtained from the participant.

You may not qualify if:

• Age under 18 years or over 40 years old.
• BMI \>25 kg/m2 and \<18.5kg/m2
• Participants who are not willing to comply with study procedures (including expression of dislike for NNS)
• Habitual NNS consumers, \>1 can of diet beverage or \>1 sachet of low calorie sweeteners per week.
• Fasting blood glucose measured \> 6 mmol/L
• Subjects who are currently dieting and having ceased a diet in \< 4 weeks
• DEBQ score for restraint eating \> 3
• Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
• Vegetarians, vegans
• Subjects who take recreational substances such as cannabis.
• Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
• Subjects with eating disorders (binge eating disorder, bulimia etc)
• Subjects who are currently experiencing anxiety or depression
• Participants who drink alcohol more than the NHS guidelines (14 units per week)
• \>10 h of vigorous physical activities per week and/or planning to increase/decrease physical activity levels in the next months.

Sponsors & Collaborators

• University of Manchester: lead
• Lancaster University: collaborator

Study Sites (1)

University of Manchester

Manchester, M13 9PG, United Kingdom

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Interventions

stevioside

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John McLaughlin

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: 2-group parallel 12-week intervention study with control group

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: February 1, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

GB (1)