Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women
NCT ID: NCT04250831
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2018-03-12
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Glucomannan, oligofructose and chromium mixture
Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie
agglomerated glucomannan, oligofructose and chromium mixture
Participants visited the University of Roehampton on three separate occasions: visit 1 (screening), visit 2 (baseline), and visit 3 (end of the trial) in total over a period of 4-weeks. During the 4-week study period, participants were instructed to replace breakfast and lunch with a shake (206 kcal/shake) each delivering 3g of the active ingredient (Mix: agglomerated glucomannan, oligofructose and chromium picolinate), and one snack bar each delivering 1.5g of the active ingredient (112 kcal/bar) in between breakfast and lunch, and lunch and dinner following by a selection of healthy dinner according to standard nutritional guidance not exceeding 1500 kcal/day. All subjects were instructed to prepare shakes by using a shaker or blender by mixing all ingredients with 200 ml of water. Participants were also instructed to consume all shakes and bars with an extra 200 ml glass of water throughout the study period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
agglomerated glucomannan, oligofructose and chromium mixture
Participants visited the University of Roehampton on three separate occasions: visit 1 (screening), visit 2 (baseline), and visit 3 (end of the trial) in total over a period of 4-weeks. During the 4-week study period, participants were instructed to replace breakfast and lunch with a shake (206 kcal/shake) each delivering 3g of the active ingredient (Mix: agglomerated glucomannan, oligofructose and chromium picolinate), and one snack bar each delivering 1.5g of the active ingredient (112 kcal/bar) in between breakfast and lunch, and lunch and dinner following by a selection of healthy dinner according to standard nutritional guidance not exceeding 1500 kcal/day. All subjects were instructed to prepare shakes by using a shaker or blender by mixing all ingredients with 200 ml of water. Participants were also instructed to consume all shakes and bars with an extra 200 ml glass of water throughout the study period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* \> 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
22 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Roehampton
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
DR ADELE COSTABILE
PI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ADELE COSTABILE, Dr
Role: STUDY_DIRECTOR
Roehampton University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LSC 18/238
Identifier Type: -
Identifier Source: org_study_id