Clinical trial NCT04250831: Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women
Official title: Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: hormones
microbiota
mood
hunger
weight loss
Lead sponsor: University of Roehampton
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 12
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, prospective, open label pilot human intervention study
Primary purpose: TREATMENT

Brief summary: Obesity is one of the greatest causes of preventable morbidity and mortality worldwide with the main treatments requiring significant changes to lifestyle, particularly dieting and physical exercise. Glucomannan is a dietary fibre that expands in the stomach, creating the feeling of fulness, while chromium can regulate insulin response.

Detailed description: The aim of this pilot study was to investigate the effect of agglomerated glucomannan, oligofructose and chromium, as part of a calorie restricted diet plan, on weight loss, satiety, satiation, mood and gut microbiome composition in a human intervention study.

Eligibility criteria: Inclusion Criteria:

* healthy female
* aged 18-65 years
* with a BMI between 25 and 35 kg/m2
* not dieting within the previous four months
* not having lost \> 5% body weight in the previous year
* not having increased physical activity levels in the past 2-4 weeks
* intending to modify them during the study
* able to eat most everyday foods

Exclusion Criteria:

* BMI \< 25 kg/m2
* \> 35 kg/m2
* significant health problems
* taking any medication or supplements known to affect appetite
* weight within the past month and/or during the study
* pregnant, planning to become pregnant or breastfeeding
* history of anaphylaxis to food
* known allergies or intolerance to foods and/or to the study materials or any of their stated ingredients.
* Volunteers who were on specific food avoidance diets
* with abnormal eating behaviour
* receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
* smokers and those who have recently ceased smoking
* Volunteers who work in appetite or feeding related areas volunteers who participated in another experimental study or receipt of

Primary outcomes:
measure: Weight loss changes from the baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in body weight from the baseline to 4 weeks intervention
measure: Body mass index changes from the baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in body mass index (calculated in Kg/m^2) from the baseline to 4 weeks intervention
measure: Blood pressure changes from the baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in blood pressure (calculated in mm/Hg) from the baseline to 4 weeks intervention
measure: Body composition changes from baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in body fat percentage (calculated in %) from the baseline to 4 weeks intervention
measure: Waist circumference changes from baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention
measure: Resting metabolic rate changes from baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention
Secondary outcomes:
measure: DNA Gut microbiome diversity changes from baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in the faecal microbiota composition and microbial activity of the volunteers using DNA profiling in faeces from the baseline to 4 weeks
measure: Hunger, mood and cravings changes from baseline to 4 weeks intervention
timeFrame: To test, in humans, changes in hunger, mood and cravings (questionnaire based analysis) from the baseline to 4 weeks intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton
state: UK
Study officials:
affiliation: Roehampton University
name: ADELE COSTABILE, Dr
role: STUDY_DIRECTOR
References: