Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

NCT04250831 | Completed

• 1 other identifier: LSC 18/238
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

hormones; microbiota; mood; hunger; weight loss

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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).

  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).

  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.

  To test, in humans, changes in waist circumference (calculated in cm) from the baseline to 4 weeks intervention

• 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).

  To test, in humans, changes in resting metabolic rate (calculated Kcal) from the baseline to 4 weeks intervention

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Glucomannan, oligofructose and chromium mixture

EXPERIMENTAL

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

Dietary Supplement: agglomerated glucomannan, oligofructose and chromium mixture

Interventions

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.

Glucomannan, oligofructose and chromium mixture

Eligibility Criteria

• Age: 22 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

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

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

oligofructose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• ADELE COSTABILE, Dr

  Roehampton University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Single group, prospective, open label pilot human intervention study

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 31, 2020
• Study Start: March 12, 2018
• Primary Completion: August 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

GB (1)