Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women (DFCP)
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|ClinicalTrials.gov Identifier: NCT04250831|
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group, prospective, open label pilot human intervention study|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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).
- 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.
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
|Health Sciences Research Centre, Life Sciences Department, University of Roehampton|
|London, UK, United Kingdom, SW15 4JD|
|Study Director:||ADELE COSTABILE, Dr||Roehampton University|