OverweightDFCPNCT04250831
Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women
A study testing agglomerated glucomannan, oligofructose and chromium mixture in people with Overweight and Obesity, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- agglomerated glucomannan, oligofructose and chromium mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- agglomerated glucomannan, oligofructose and chromium mixture
- Keywords
- hormones, microbiota, mood, hunger, weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agglomerated glucomannan, oligofructose and chromium mixtureDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucomannan, oligofructose and chromium mixture | Experimental | Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie Receives: Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss changes from the baseline to 4 weeks intervention
The body mass was measured to the nearest 0.1 kg using a digital balance scale (Seca 707, Seca Corporation, Hamburg, Germany)
Measured: To test, in humans, changes in body weight from the baseline to 4 weeks intervention
Body mass index changes from the baseline to 4 weeks intervention
Body mass index was determined as weight divided by height squared (kg/m^2)
Measured: To test, in humans, changes in body mass index (calculated in Kg/m^2) from the baseline to 4 weeks intervention
Blood pressure changes from the baseline to 4 weeks intervention
Blood pressure was measured using a digital blood pressure monitor (Nissei, model DS-1902, Japan Precision Instruments, Inc., Gunma, Japan).
Measured: To test, in humans, changes in blood pressure (calculated in mm/Hg) from the baseline to 4 weeks intervention
Body composition changes from baseline to 4 weeks intervention
Body fat percentage was assessed after a 12-hour water-only fast by bioelectrical impedance analysis (BIA) method, using a Tanita BC-418 MA Segmental Body Composition Analyser, which incorporates eight tactile electrodes (Tanita Corporation, Tokyo, Japan).
Measured: To test, in humans, changes in body fat percentage (calculated in %) from the baseline to 4 weeks intervention
Waist circumference changes from baseline to 4 weeks intervention
Waist was assessed using anthropometric tape (Seca 201, Hamburg, Germany) over light clothing to the nearest 0.1 centimetre while the subjects were in the standing position at the end of gentle expiration. The waist circumference was measured at the mid-point between the lowest rib margin and anterior superior iliac crest and hip circumference was measured at the maximum protuberance of the buttocks, and the waist-to-hip ratio was calculated by dividing waist circumference by hip circumference.
Measured: To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention
Resting metabolic rate changes from baseline to 4 weeks intervention
Resting metabolic rate (RMR) before and at the end of the 4-week intervention was determined by indirect calorimetry using the breath-by-breath system of recording (Cortex MetaLyzer 3B device).
Measured: To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention
Secondary outcomes (2)
DNA Gut microbiome diversity changes from baseline to 4 weeks intervention
Sequencing was performed on an Illumina MiSeq desktop sequencer using the MiSeq Reagent Kit V2 (Illumina, San Diego). The significance in the abundance of the relevant taxa were validated by Wilcoxon signed-rank tests (16s rRNA sequencing using Illumina MiSeq Platform and QIIME data analysis software).
Measured: 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
Hunger, mood and cravings changes from baseline to 4 weeks intervention
Changes in hunger, mood and craving was determined via Control of Eating Questionnaire (CoEQ) comprised of twenty items to assess the intensity and type of food cravings each participant experienced over the previous 7 days, as well as subjective sensations of appetite and mood. Responses were recorded using the visual analogue scale.
Measured: To test, in humans, changes in hunger, mood and cravings (questionnaire based analysis) from the baseline to 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start12 Mar 2018
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, prospective, open label pilot human intervention study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, Dr, Study director, Roehampton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250831
- Sponsor's protocol ID
- LSC 18/238
- Acronym
- DFCP
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT04250831
- Acronym / sponsor ID
- DFCP / LSC 18/238
- Conditions
- Overweight, Obesity
- Keywords
- hormones, microbiota, mood, hunger, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, prospective, open label pilot human intervention study
| Arm | Type | Receives |
|---|---|---|
| Glucomannan, oligofructose and chromium mixture | Experimental | Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixtureAgglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agglomerated glucomannan, oligofructose and chromium mixtureParticipants 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. | Dietary supplement | Glucomannan, oligofructose and chromium mixture |
Primary outcome
Weight loss changes from the baseline to 4 weeks intervention
Time frame: To test, in humans, changes in body weight from the baseline to 4 weeks intervention
The body mass was measured to the nearest 0.1 kg using a digital balance scale (Seca 707, Seca Corporation, Hamburg, Germany)
Body mass index changes from the baseline to 4 weeks intervention
Time frame: To test, in humans, changes in body mass index (calculated in Kg/m^2) from the baseline to 4 weeks intervention
Body mass index was determined as weight divided by height squared (kg/m^2)
Blood pressure changes from the baseline to 4 weeks intervention
Time frame: To test, in humans, changes in blood pressure (calculated in mm/Hg) from the baseline to 4 weeks intervention
Blood pressure was measured using a digital blood pressure monitor (Nissei, model DS-1902, Japan Precision Instruments, Inc., Gunma, Japan).
Body composition changes from baseline to 4 weeks intervention
Time frame: To test, in humans, changes in body fat percentage (calculated in %) from the baseline to 4 weeks intervention
Body fat percentage was assessed after a 12-hour water-only fast by bioelectrical impedance analysis (BIA) method, using a Tanita BC-418 MA Segmental Body Composition Analyser, which incorporates eight tactile electrodes (Tanita Corporation, Tokyo, Japan).
Waist circumference changes from baseline to 4 weeks intervention
Time frame: To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention
Waist was assessed using anthropometric tape (Seca 201, Hamburg, Germany) over light clothing to the nearest 0.1 centimetre while the subjects were in the standing position at the end of gentle expiration. The waist circumference was measured at the mid-point between the lowest rib margin and anterior superior iliac crest and hip circumference was measured at the maximum protuberance of the buttocks, and the waist-to-hip ratio was calculated by dividing waist circumference by hip circumference.
Resting metabolic rate changes from baseline to 4 weeks intervention
Time frame: To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention
Resting metabolic rate (RMR) before and at the end of the 4-week intervention was determined by indirect calorimetry using the breath-by-breath system of recording (Cortex MetaLyzer 3B device).
2 secondary outcomes
DNA Gut microbiome diversity changes from baseline to 4 weeks intervention
Time frame: 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
Hunger, mood and cravings changes from baseline to 4 weeks intervention
Time frame: To test, in humans, changes in hunger, mood and cravings (questionnaire based analysis) from the baseline to 4 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADELE COSTABILE, Dr study director
Roehampton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing agglomerated glucomannan, oligofructose and chromium mixture in people with Overweight and Obesity, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss changes from the baseline to 4 weeks intervention (time frame: To test, in humans, changes in body weight from the baseline to 4 weeks intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.