Appetite Regulation, Obesity
Conditions
Keywords
Appetite regulation, Oligofructose intake
Brief summary
This study seeks to look into the effects of oligofructose supplementation on appetite, energy intake, and body weight and body composition in overweight subjects. Compared to a placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby reduce food intake moderately leading to a decrease in body weight.
Detailed description
Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties. This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host. Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively. It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.
Interventions
DIETARY_SUPPLEMENTOligofructose
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
DIETARY_SUPPLEMENTPlacebo
Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females aged 20-50 * BMI 25-35 kg/m2 * Weight stable for three months prior to enrollment in study (weight change \< 3 kg over a period of three months) * Habitual dietary fibre ≤ 25g/day (as assessed by 3-day dietary record) * Non-smokers * No current or history of endocrine disease, gastrointestinal disease, kidney or liver diseases, cardiovascular disease, pancreatitis, or cancer * Hydrogen producers
Exclusion criteria
* Use of antibiotic less than three months prior to participation in the study * Participation in other research studies in the previous three months * Blood donation less than three months before participation in study * Anaemia * Hypertension * Pregnancy or breastfeeding * Substance abuse * Vegan diet * Regular use of prebiotic, probiotic or symbiotic food items/ supplements * Intense exercise undertaken for more than 5h per week * Metallic or electronic implants e.g. pacemaker, cochlear ear implants, fixed dental braces * Claustrophobia * Depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Appetite Ratings in Hunger Compared to Baseline | Baseline, 56 days | Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days |
| Subjective Appetite Ratings in Fullness Compared to Baseline | Baseline, 56 days | Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days |
| Body Weight | Baseline, 56 days | — |
| Energy Intake | Baseline, 56 days | Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software. The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data). |
| Gut Hormone PYY | baseline (Day 0) and post-supplementation (Day 56) | Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Insulin | baseline (Day 0) and post-supplementation (Day 56) | Plasma insulin concentrations were assayed using RIA kits (Millipore, MO). |
| Body Composition | Baseline, 56 days | Body composition assessed by BMI |
| Breath Hydrogen Levels | baseline (Day 0) and post-supplementation (Day 56) | breath hydrogen were obtained from volunteers throughout the study session. |
| Imaging of Total Adipose Tissue | Baseline, 56 days | Total adipose tissue was assessed by FMRI at baseline and after treatment period |
| Plasma Short-chain Fatty Acids Concentrations After Treatment | Baseline, 56 days | Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography |
| Inflammatory Markers | baseline (Day 0) and post-supplementation (Day 56) | No data were collected for this Outcome Measure |
| Glycemic Response | baseline (Day 0) and post-supplementation (Day 56) | Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oligofructose Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. | 12 |
| Cellulose and Maltodextrin Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Oligofructose | Cellulose and Maltodextrin | Total |
|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 2.2 | 28.7 years STANDARD_DEVIATION 2.3 | 32 years STANDARD_DEVIATION 2 |
| BMI | 29.7 kg/m^2 STANDARD_DEVIATION 1 | 31.1 kg/m^2 STANDARD_DEVIATION 1.1 | 30.5 kg/m^2 STANDARD_DEVIATION 1.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
| waist:hip ratio (WHR) | 0.86 ratio STANDARD_DEVIATION 0.03 | 0.82 ratio STANDARD_DEVIATION 0.02 | 0.84 ratio STANDARD_DEVIATION 0.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Body Weight
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Body Weight | Baseline | 83.7 kg | Standard Error 4.9 |
| Oligofructose | Body Weight | 56 days | 84.1 kg | Standard Error 4.8 |
| Cellulose and Maltodextrin | Body Weight | Baseline | 86 kg | Standard Error 4.4 |
| Cellulose and Maltodextrin | Body Weight | 56 days | 86.3 kg | Standard Error 4.5 |
Comparison: after treatment, 56 daysp-value: 0.715t-test, 2 sided
Primary
Energy Intake
Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software. The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data).
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Energy Intake | Baseline | 873.16 kcal | Standard Error 54.06 |
| Oligofructose | Energy Intake | 56 days | 760.19 kcal | Standard Error 51.59 |
| Cellulose and Maltodextrin | Energy Intake | Baseline | 867.61 kcal | Standard Error 159.45 |
| Cellulose and Maltodextrin | Energy Intake | 56 days | 725.34 kcal | Standard Error 117.4 |
p-value: 0.578ANCOVA
Comparison: baseline to after treatment, at 56 daysp-value: 0.007t-test, 2 sided
Comparison: baseline to after treatment, at 56 daysp-value: 0.05t-test, 2 sided
Primary
Gut Hormone PYY
Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Population: The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8. PubMed ID: 24715424 for graph)
Primary
Subjective Appetite Ratings in Fullness Compared to Baseline
Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Subjective Appetite Ratings in Fullness Compared to Baseline | Baseline | 4.7 units on a scale | Standard Error 0.5 |
| Oligofructose | Subjective Appetite Ratings in Fullness Compared to Baseline | 56 days | 4.2 units on a scale | Standard Error 0.8 |
| Cellulose and Maltodextrin | Subjective Appetite Ratings in Fullness Compared to Baseline | Baseline | 4.2 units on a scale | Standard Error 0.8 |
| Cellulose and Maltodextrin | Subjective Appetite Ratings in Fullness Compared to Baseline | 56 days | 4.1 units on a scale | Standard Error 0.6 |
p-value: 0.688ANCOVA
Primary
Subjective Appetite Ratings in Hunger Compared to Baseline
Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Subjective Appetite Ratings in Hunger Compared to Baseline | baseline | 4.8 cm | Standard Error 0.9 |
| Oligofructose | Subjective Appetite Ratings in Hunger Compared to Baseline | 56 days | 3.6 cm | Standard Error 0.8 |
| Cellulose and Maltodextrin | Subjective Appetite Ratings in Hunger Compared to Baseline | baseline | 3.6 cm | Standard Error 0.8 |
| Cellulose and Maltodextrin | Subjective Appetite Ratings in Hunger Compared to Baseline | 56 days | 4.1 cm | Standard Error 0.6 |
p-value: 0.135ANCOVA
Secondary
Body Composition
Body composition assessed by BMI
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Body Composition | Baseline | 29.7 kg/m^2 | Standard Error 1 |
| Oligofructose | Body Composition | 56 days | 29.9 kg/m^2 | Standard Error 1.1 |
| Cellulose and Maltodextrin | Body Composition | Baseline | 31.1 kg/m^2 | Standard Error 1.1 |
| Cellulose and Maltodextrin | Body Composition | 56 days | 31.2 kg/m^2 | Standard Error 1.1 |
Secondary
Breath Hydrogen Levels
breath hydrogen were obtained from volunteers throughout the study session.
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Population: The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8. PubMed ID: 24715424 for graph)
Secondary
Glycemic Response
Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).
Time frame: baseline (Day 0) and post-supplementation (Day 56)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oligofructose | Glycemic Response | 4.8 mmol/L |
| Cellulose and Maltodextrin | Glycemic Response | 4.7 mmol/L |
Secondary
Imaging of Total Adipose Tissue
Total adipose tissue was assessed by FMRI at baseline and after treatment period
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Imaging of Total Adipose Tissue | Baseline | 36.3 percentage of body fat | Standard Error 2.8 |
| Oligofructose | Imaging of Total Adipose Tissue | 56 days | 37 percentage of body fat | Standard Error 2.8 |
| Cellulose and Maltodextrin | Imaging of Total Adipose Tissue | Baseline | 38.4 percentage of body fat | Standard Error 3.7 |
| Cellulose and Maltodextrin | Imaging of Total Adipose Tissue | 56 days | 38.7 percentage of body fat | Standard Error 3.8 |
Secondary
Inflammatory Markers
No data were collected for this Outcome Measure
Time frame: baseline (Day 0) and post-supplementation (Day 56)
Population: Inflammatory markers where never measured for this study and so therefore no results available.
Secondary
Plasma Short-chain Fatty Acids Concentrations After Treatment
Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography
Time frame: Baseline, 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oligofructose | Plasma Short-chain Fatty Acids Concentrations After Treatment | Acetate | 81.3 uM | Standard Error 2.1 |
| Oligofructose | Plasma Short-chain Fatty Acids Concentrations After Treatment | Propionate | 5.4 uM | Standard Error 0.6 |
| Oligofructose | Plasma Short-chain Fatty Acids Concentrations After Treatment | Butyrate | 0.9 uM | Standard Error 0.1 |
| Cellulose and Maltodextrin | Plasma Short-chain Fatty Acids Concentrations After Treatment | Acetate | 72.8 uM | Standard Error 1.8 |
| Cellulose and Maltodextrin | Plasma Short-chain Fatty Acids Concentrations After Treatment | Propionate | 5.4 uM | Standard Error 0.6 |
| Cellulose and Maltodextrin | Plasma Short-chain Fatty Acids Concentrations After Treatment | Butyrate | 0.7 uM | Standard Error 0.2 |
Comparison: Acetatep-value: 0.024ANCOVA
Secondary
Serum Insulin
Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Time frame: baseline (Day 0) and post-supplementation (Day 56)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oligofructose | Serum Insulin | 10.2 (mU/L |
| Cellulose and Maltodextrin | Serum Insulin | 9.6 (mU/L |