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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05449665
Other study ID # 813
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 14, 2022
Est. completion date December 31, 2023

Study information

Verified date May 2024
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive) - low habitual fibre intake (<10g/day) Exclusion Criteria: Medication exclusion criteria: - antibiotic use (within the past 3 months due to impact on gut microbiota) - statins (current) - aspirin or other NSAIDs or anti-coagulants (current) - anti-depressants (current) - smoking or vaping Medical exclusion criteria: - Females who are planning to be pregnant, are pregnant or are breastfeeding - Anyone with food allergies, self-reported food sensitivity or intolerance - Anyone with coeliac disease or gluten intolerance - Anyone taking medication which may affect their appetite - Anyone with an eating disorder - Anyone with diabetes - Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout - Anyone suffering from a psychiatric disorder or any type of substance abuse - Anyone suffering from unregulated thyroid disease Other exclusion criteria: - Anyone following a vegetarian or vegan diet - Anyone following a weight loss programme (that may be affecting lifestyle, physical activity & diet) - Anyone with unsuitable veins for blood sampling - Anyone who is unable to fluently speak, read and understand English - Anyone who is unable to comply to an alcohol-free diet for 6 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Phase 1 - Control
Control diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d). Fed to energy balance (1.5 x Resting Metabolic Rate, RMR).
Phase 2 - High Fibre
High Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 30g/day Fibre). Fed ad libitum, contains 20g/day pectin (split over breakfast, lunch and dinner) in drinks/yoghurts which will be compulsory to consume and 10g/day fibre coming from the diet provided.
Phase 3 - Low Fibre
Low Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 10g/day Fibre). Fed ad libitum.

Locations

Country Name City State
United Kingdom Rowett Institute, University of Aberdeen Aberdeen

Sponsors (1)

Lead Sponsor Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in blood metabolites in response to dietary fibre measured by acute and chronic changes in plasma short chain fatty acids (SCFA) At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in lipid profile in response to dietary fibre measured by change in fasting plasma lipid profile (cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and non-esterified fatty acids (NEFA) At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in diet markers in response to dietary fibre measured by change in urinary metabolites At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Height measured in metres At screening visit only
Other Change in body weight in response to dietary fibre measured as weight in kilograms At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in blood pressure in response to dietary fibre measured as mmHg on each test day At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in waist and hip circumferences in response to dietary fibre measured as in cm with a tape measure on each test day At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in waist to hip ratio in response to dietary fibre waist and hip measures will be combined to report waist to hip ratio At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in Body Mass Index (BMI) in response to dietary fibre weight and height measures will be combined to report BMI in kg/m^2 At baseline and end of each arm (study days 0, 14, 28 and 42)
Other Change in gastrointestinal symptoms in response to dietary fibre measured daily, at end of day, using questionnaires every day of study (42days)
Other Change in appetite in response to dietary fibre measured daily, at end of day, using visual analogue scale questionnaires every day of study (42days)
Other Change in free-living glycaemic control in response to dietary fibre measured using continuous glucose monitoring (CGM) every day of study (42days)
Other Change in food intake measured using weighed intake records at screening (7days) and every day of study (42days)
Primary Change in gut hormones to assess appetite response to dietary fibre measured by acute and chronic changes in plasma ghrelin and peptide YY (PYY) At baseline and end of each arm (study days 0, 14, 28 and 42)
Primary Change in subjective hunger to assess appetite response to dietary fibre measured by acute and chronic changes in appetite using visual analogue scale questionnaires At baseline and end of each arm (study days 0, 14, 28 and 42)
Secondary Change in gut metabolites (from faecal samples) in response to dietary fibre measured by changes in faecal short chain fatty acids concentrations At baseline and end of each arm (study days 0, 14, 28 and 42)
Secondary Change in gut microbiome composition (from faecal samples) in response to dietary fibre measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA At baseline and end of each arm (study days 0, 14, 28 and 42)
Secondary Change in glycaemic control in response to dietary fibre measured by acute and chronic changes in plasma glucose and insulin At baseline and end of each arm (study days 0, 14, 28 and 42)
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