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Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women (DFCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250831
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
DR ADELE COSTABILE, University of Roehampton

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, prospective, open label pilot human intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Glucomannan, oligofructose and chromium mixture
Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie
Dietary Supplement: 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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).

  4. 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).

  5. 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.

  6. 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).


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250831


Locations
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United Kingdom
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom, SW15 4JD
Sponsors and Collaborators
University of Roehampton
Investigators
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Study Director: ADELE COSTABILE, Dr Roehampton University
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Responsible Party: DR ADELE COSTABILE, PI, University of Roehampton
ClinicalTrials.gov Identifier: NCT04250831    
Other Study ID Numbers: LSC 18/238
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DR ADELE COSTABILE, University of Roehampton:
hormones
microbiota
mood
hunger
weight loss
Additional relevant MeSH terms:
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Overweight
Body Weight
Chromium
(1-6)-alpha-glucomannan
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents