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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
agglomerated glucomannan, oligofructose and chromium mixture
Sponsored by
University of Roehampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring hormones, microbiota, mood, hunger, weight loss

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Health Sciences Research Centre, Life Sciences Department, University of Roehampton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glucomannan, oligofructose and chromium mixture

Arm Description

Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie

Outcomes

Primary Outcome Measures

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)
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)
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).
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).
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.
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).

Secondary Outcome Measures

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).
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.

Full Information

First Posted
January 24, 2020
Last Updated
January 29, 2020
Sponsor
University of Roehampton
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1. Study Identification

Unique Protocol Identification Number
NCT04250831
Brief Title
Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women
Acronym
DFCP
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roehampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
hormones, microbiota, mood, hunger, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, prospective, open label pilot human intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucomannan, oligofructose and chromium mixture
Arm Type
Experimental
Arm Description
Agglomerated glucomannan, oligofructose and chromium mixture as the functional ingredient in a calorie
Intervention Type
Dietary Supplement
Intervention Name(s)
agglomerated glucomannan, oligofructose and chromium mixture
Intervention Description
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 Measure Information:
Title
Weight loss changes from the baseline to 4 weeks intervention
Description
The body mass was measured to the nearest 0.1 kg using a digital balance scale (Seca 707, Seca Corporation, Hamburg, Germany)
Time Frame
To test, in humans, changes in body weight from the baseline to 4 weeks intervention
Title
Body mass index changes from the baseline to 4 weeks intervention
Description
Body mass index was determined as weight divided by height squared (kg/m^2)
Time Frame
To test, in humans, changes in body mass index (calculated in Kg/m^2) from the baseline to 4 weeks intervention
Title
Blood pressure changes from the baseline to 4 weeks intervention
Description
Blood pressure was measured using a digital blood pressure monitor (Nissei, model DS-1902, Japan Precision Instruments, Inc., Gunma, Japan).
Time Frame
To test, in humans, changes in blood pressure (calculated in mm/Hg) from the baseline to 4 weeks intervention
Title
Body composition changes from baseline to 4 weeks intervention
Description
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).
Time Frame
To test, in humans, changes in body fat percentage (calculated in %) from the baseline to 4 weeks intervention
Title
Waist circumference changes from baseline to 4 weeks intervention
Description
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.
Time Frame
To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention
Title
Resting metabolic rate changes from baseline to 4 weeks intervention
Description
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).
Time Frame
To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention
Secondary Outcome Measure Information:
Title
DNA Gut microbiome diversity changes from baseline to 4 weeks intervention
Description
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).
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
Title
Hunger, mood and cravings changes from baseline to 4 weeks intervention
Description
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.
Time Frame
To test, in humans, changes in hunger, mood and cravings (questionnaire based analysis) from the baseline to 4 weeks intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADELE COSTABILE, Dr
Organizational Affiliation
Roehampton University
Official's Role
Study Director
Facility Information:
Facility Name
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
City
London
State/Province
UK
ZIP/Postal Code
SW15 4JD
Country
United Kingdom

12. IPD Sharing Statement

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Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

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