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Completed

NCT Number: NCT04250831

Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

22 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

London, UK, SW15 4JD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

agglomerated glucomannan, oligofructose and chromium mixture

Dietary 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study title

Impact of Dietary Fibre and Chromium Picolinate on Satiety, Satiation, Weight Loss and Gut Microbiome Composition in Overweight and Obese Women

Acronym: DFCP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2020
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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