On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota

Lund University

Status: Completed

Conditions: Healthy Subjects

Treatments: Other: saccharin; Other: Sucrose; Other: Stevia glycosides

Study type: Interventional

Funder types: Other

Identifiers

NCT02580110

2015/57

Details and patient eligibility

About

The study intention is to investigate, in healthy humans, effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition.

Full description

Healthy subjects will be included in a crossover study with the purpose to investigate effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition. The subjects will consume each test product for 14 days in a random order, separated by at least a two-week washout period. On the last day in each intervention period, i.e. at day fifteen, the last test portion will be consumed together with a standardized evening meal at 9.00 pm. Thereafter the subjects are fasting until arriving to the experimental unit. Upon arrival, test variables in blood will be determined at fasting and repeatedly for 3h postprandial a standardised breakfast served approximately at 8.00 am. Cognitive performance will be determined in the postprandial period with tests evaluating working memory capacity, selective attention, psychomotor reaction time, and executive functions. After each intervention period, faecal samples will be collected for characterization of gut microflora.

Enrollment: 39 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy subjects
• blood glucose <6.1
• BMI <28
• age between 40-70 years
• normal diet
• fluent in Swedish language (due to the structure of the cognitive tests).

Exclusion criteria

• diabetes
• cognitive decline (not able to cope with the cognitive tests)
• metabolic syndrome
• gastro-intestinal disorders
• antibiotics or probiotics during the study period
• smookers

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 3 patient groups

sucrose

Experimental group

Description:

14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.

Treatment:

Other: Sucrose

stevia glycosides

Experimental group

Description:

14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.

Treatment:

Other: Stevia glycosides

saccharin

Experimental group

Description:

14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.

Treatment:

Other: saccharin