Acceptance of increased daily dietary fibre in healthy participants: A preliminary feasibility study to inform a larger RCT to test the efficacy of barley on body composition and weight loss.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001440819

Enrollment

Registered

2021-10-25

Start date

2019-10-28

Completion date

2020-11-27

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Participants were randomised into one of three groups with different levels of fibre. This trial is a feasibility study that aimed to assess the acceptability of additional fibre in the daily diet (through BARLEYmax). This is in order to inform a larger randomised controlled trial that aims to explore the effect of increasing fibre intake on body composition and weight loss. We hypothesised that BARLEYmax would be a safe, well accepted supplement, that would increase satiety.

Interventions

Participants will be randomly assigned to one of three conditions at study entry: (1) Receive two daily servings of 25 gram of fibre (in the form of BARLEYmax) for 3 weeks. BARLEYmax in the form of flakes and will be added into meals i.e. breakfast cereal, desert. (FIBREmax). (2) Receive two daily servings of BARLEYmax. However, the amount of fibre will be gradually increased over the 3 week period (week 1 = 8 gr per serving; week 2 = 16 gr per serving; week 3 = 25 gr per serving). (FIBREgrad) or (3) Placebo. Two daily servings of 25 grams placebo product in the form of flakes and will be added into meals i.e. breakfast cereal, desert. Adherence was monitored by asking participants at end of study. How closely have you followed the use of the flakes as recommended?'

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Aged between 18 and 50 years of age; 2. Male or female; 3. Have a body mass index between 18.5-34.9 Kg.m-2.

Exclusion criteria

1. Have a history or presence of a comorbid disease for which diet modifications may be contraindicated (e.g., diabetes, metabolic syndrome, polycystic ovary syndrome, hypoproteinemia). 2. Have a history of eating disorders. 3. Have a history of bariatric surgery. 4. Currently taking, or have taken in the last 3 months, dietary supplements for thyroid, hyperlipidemia, hypoglycaemia, or weight loss supplements (e.g., ephedra, thermogenic compounds). 5. Not have participated in a diet or clinical trial in the last 6 months. 6. Females only: pre-menopausal, menopausal, are currently pregnant or are currently breastfeeding. 7. Mental or cognitive impairment that limits ability to understand test instructions.

Outcome results