DFCP: Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

Sponsor

University of Roehampton (Other)

Overall Status

Completed

CT.gov ID

NCT04250831

Collaborator

(none)

Enrollment

Location

Arm

6.6

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixture	N/A

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

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group, prospective, open label pilot human intervention studySingle 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 :

Mar 12, 2018

Actual Primary Completion Date :

Aug 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Weight loss changes from the baseline to 4 weeks intervention [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 [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 [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 [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 [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 [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

DNA Gut microbiome diversity changes from baseline to 4 weeks intervention [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).
Hunger, mood and cravings changes from baseline to 4 weeks intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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