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The Effect of Lactisole on the Responses to Glucose Solution

N

Northern Care Alliance NHS Foundation Trust

Status

Unknown

Conditions

Blood Glucose
Hormones
Therapeutic Uses
Appetite

Treatments

Dietary Supplement: Lactisole

Study type

Interventional

Funder types

Other

Identifiers

NCT01121783
Lactisole

Details and patient eligibility

About

The purpose of the study is to determine whether the sweet taste receptors in the gut are involved in sensing sweet substances and controlling appetite and the amount we eat. Lactisole is a substance commonly used in food products to reduce the perceived sweetness of certain sugars and sweeteners. The aim of this study is to investigate whether the responses to a glucose solution, intragastrically administered to healthy male and female volunteers, is affected by the presence of lactisole in the gut. Understanding the mechanisms by which nutrients are initially detected in the gut and how they influence food intake is critical to the development of novel food products that could reduce food consumption.

Full description

Obesity is epidemically prevalent and a major risk factor for chronic diseases making it fundamental to understand the pathways controlling food intake. During the course of a meal and afterwards the gut and brain communicate to control how full the eater feels and thus control the amount of food eaten. The information relayed from the gut to the brain regarding ingested nutrients is of increasing importance and understanding the mechanisms by which nutrient molecules are initially detected in the gut and how they signal to the brain to influence food intake is critical to the development of novel food products that could induce fullness and reduce food consumption. Increasing our understanding of how nutrients are sensed in the gut and how this may influence subsequent food intake provides promising targets for obesity prevention and treatment. Recent discoveries have shown that sweet taste receptors similar to those located in the tongue are present in the gut. It is suggested that theses receptors are involved in the way nutrients are sensed and may play an important role in appetite control and food intake.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged between 18-45 years
  • BMI between 18-25kg/m2
  • General good health

Exclusion criteria

  • Underweight or Overweight (Body Mass Index <19 or >25 kg.m-2)
  • Females who are pregnant or breastfeeding
  • Currently taking medication (except females taking oral contraceptive)
  • Smokers
  • Currently dieting or have experienced a weight change +/- 3kg in past 6 months
  • Metabolic disorders (eg. Type 2 diabetes)
  • History of gastrointestinal disorders
  • Participation in other research in past 3 months

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

24 participants in 4 patient groups, including a placebo group

Lactisole-Glucose
Active Comparator group
Lactisole-water
Active Comparator group
Treatment:
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Water-Glcuose
Placebo Comparator group
Treatment:
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Water-Water
Placebo Comparator group
Treatment:
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole
Dietary Supplement: Lactisole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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