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The Leeds Women's Wellbeing (LWW) Study

U

University of Leeds

Status

Completed

Conditions

Weight Loss

Treatments

Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day

Study type

Interventional

Funder types

Other

Identifiers

NCT01539369
10/H1305/6

Details and patient eligibility

About

The purpose of this parallel design study is to assess the relative effects of two 12-week healthy eating dietary interventions: general healthy eating (Diet A) and general healthy eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran), in overweight low-fibre consuming premenopausal female adults on body weight change (kg). It is hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).

Full description

In this randomised, single blind, parallel design study participants were randomly assigned to one of two 12-week healthy eating dietary interventions: Diet A: general healthy eating OR Diet B: general healthy eating combined with advice to increase fibre intake to at least 25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran.

Enrollment

80 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female
  • 18-48 years of age (premenopausal)
  • Self reported good health
  • Body Mass Index (BMI) within overweight/obese range (26-35kg/m2)
  • Willingness to consume study foods and prepared to eat breakfast cereals as part of the intervention
  • Non-smokers or given up more than 6 months ago
  • Exercising no more than 4 times per week at a medium intensity
  • Weight stable in the last 3 months (fluctuation of no more than 3kg)
  • Current fibre intake (≤ 15g/day) according to DINE and verified by 7 day food diary (fibre points)
  • Ability to adequately understand verbal and written information in English

Exclusion criteria

  • Menopausal or showing menopausal symptoms (e.g. frequent/recurrent hot flushes) at screening or taking any supplements for menopausal symptoms
  • Type 2 Diabetes; Cardiac pacemaker fitted
  • Taking medication and/or supplements known to affect appetite/body weight in the last 6 months (e.g. asthma, steroids, anti-depressants)
  • BMI outside range of 26-35 kg/m2
  • Food allergies or aversions to foods likely to be consumed within the study (e.g. wheat bran, nuts)
  • Non-smokers or given up more than 6 months ago
  • Exercising more than 4 times per week at a medium intensity
  • Shift work (night shifts)
  • Pregnant or planning a pregnancy within the next year; having been pregnant or lactating within the previous 6 months
  • No history of, or current eating disorders as determined using the Eating Attitudes Test (EAT-26;Gardner et al., 1982; a score higher than 20)
  • Current fibre intake (>15g/day according to DINE)
  • Insufficient English language skills to complete all study questionnaires

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

High fibre diet
Experimental group
Treatment:
Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
Healthy eating diet
Active Comparator group
Treatment:
Other: Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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