Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

University of Roehampton12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight Obesity

Interventions

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.

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

London, UK, United Kingdom

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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).

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

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