Effects of Prebiotic-based Snacks on the Gut Microbiota and Perceived 'Satisfaction' (NutriSAT)

University of Reading

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Nutriose FB06

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02041975

H5117800

Ethics No. 11/08 (Other Identifier)

Details and patient eligibility

About

To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals

Full description

The role of the bacteria that reside in the human gut play in human health and disease is of increasing importance. Evidence gathered over recent decades' shows that certain bacteria can improve resistance to gut infections, reduce cholesterol levels, synthesise vitamins and improve the immune response. The potential to modulate the relative balance of these so-called 'beneficial' bacteria has been demonstrated through the use of certain fibre sources termed prebiotics. In addition there is interest to understand how snacks containing these fibre sources may affect levels of 'satisfaction' between meals. The current study will address these issues and lead to a greater understanding of the role that prebiotics may play in gut health and overall metabolism.

Enrollment

47 patients

Sex

All

Ages

22 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria -

Aged between 22 and 55 years
Healthy (no medical conditions in the last 12 months)
BMI between 22.0 and 27.9 kg/m2
Non-smokers
Not a vegetarian or vegan
No antibiotics in the last 6 months
Not donated more than 350 ml blood in 4 months prior to or following study

Exclusion Criteria -

Had surgery or suffered a medical condition affecting the circulatory, nervous or digestive systems in the previous 12 months
Had suffered a myocardial infarction or stroke in the previous 12 months
Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting
Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)
Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease [including proton pump inhibitors (e.g. Omeprazole, Esomeprazole, Lansoprazole or Pantoprazole), non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen or diclofenac) or anti-anxiety medication (e.g. benzodiazepine)]
Use of antibiotics within the previous 6 months
Any dietary restrictions or on a weight reducing diet
Irregular eating patterns and those not consuming breakfast
Any food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)
Use of medication which affects food intake or behaviour (e.g. anti-depressants)
Use of medication likely to affect taste, smell or appetite
Use of cholesterol lowering drugs/functional foods (e.g. Flora pro-activ)
Dietary fibre consumption > 20 g/d
Those that dislike the study foods and beverages
Three Factor Eating Questionnaire (TFEQ) Factor 1 score >13
Use of any vitamin supplements or fish oil capsules
A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men)
Smoking
Athletes in training (> 8 h exercise/week)
Amount of sleep each night (<5 hours/night)
Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
Involvement in a study involving an experimental drug/medication within 4 weeks prior to entry to the study
History of chronic constipation or diarrhoea, or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
Intake of other supplementary prebiotics (such as oligosaccharides, e.g. FOS, GOS) or probiotics, drugs active on gastrointestinal motility such as antidiarrheals (e.g. medicines containing loperamide, bismuth subsalicyte or atropine/diphenoxylate), medication for abdominal pain and intestinal discomfort (e.g. duspatalin) or laxatives of any class (medications containing e.g. polyethylene glycol 3350, bisacodyl, methylcellulose or lactulose) during or within the four weeks prior to the start of the study
Aged below 22 or over 55 years
Have a Body Mass Index (BMI) of less than 22 or more than 27.9 kg/m2 [for volunteers of Asian origin; BMI of less than 21, or between to 23 to 25, or above 27 kg/m2].
Blood pressure > 160/90 mmHg
Vegan or vegetarian
Donated > 350 ml of blood within the 4 months prior to the study or plan on donating > 350 ml of blood within the 4 months following the study.