Effect of Oligofructose on Appetite in Overweight Subjects

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT00912197
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 26
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appetite Regulation; Obesity	Dietary Supplement: Oligofructose; Dietary Supplement: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
• Actual Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oligofructose Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.	Dietary Supplement: Oligofructose; Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
Placebo Comparator: Cellulose and maltodextrin Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.	Dietary Supplement: Placebo; 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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Body Weight [Baseline, 56 days]

4. 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).

5. 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 Outcome Measures

1. Body Composition [Baseline, 56 days]

   Body composition assessed by BMI

2. Imaging of Total Adipose Tissue [Baseline, 56 days]

   Total adipose tissue was assessed by FMRI at baseline and after treatment period

3. 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

4. Inflammatory Markers [baseline (Day 0) and post-supplementation (Day 56)]

   No data were collected for this Outcome Measure

5. 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).

6. Serum Insulin [baseline (Day 0) and post-supplementation (Day 56)]

   Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).

7. Breath Hydrogen Levels [baseline (Day 0) and post-supplementation (Day 56)]

   breath hydrogen were obtained from volunteers throughout the study session.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College London, Hammersmith Hospital	London		United Kingdom	W12 0NN

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Gary S Frost, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT00912197
• Other Study ID Numbers: CRO1243
• First Posted: Jun 3, 2009
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Appetite regulation; Oligofructose intake
• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Period Title: Overall Study
STARTED	15	13
COMPLETED	12	10
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin	Total
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in	Total of all reporting groups
Overall Participants	12	10	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.5 (2.2)	28.7 (2.3)	32 (2)
Sex: Female, Male (Count of Participants)
Female	9 75%	7 70%	16 72.7%
Male	3 25%	3 30%	6 27.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	12 100%	10 100%	22 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.7 (1.0)	31.1 (1.1)	30.5 (1.1)
waist:hip ratio (WHR) (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	0.86 (0.03)	0.82 (0.02)	0.84 (0.02)

Outcome Measures

1. Primary Outcome

Title	Subjective Appetite Ratings in Hunger Compared to Baseline
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
baseline	4.8 (0.9)	3.6 (0.8)
56 days	3.6 (0.8)	4.1 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oligofructose, Cellulose and Maltodextrin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.135
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Subjective Appetite Ratings in Fullness Compared to Baseline
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Baseline	4.7 (0.5)	4.2 (0.8)
56 days	4.2 (0.8)	4.1 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oligofructose, Cellulose and Maltodextrin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.688
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Body Weight
Time Frame	Baseline, 56 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Baseline	83.7 (4.9)	86 (4.4)
56 days	84.1 (4.8)	86.3 (4.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oligofructose, Cellulose and Maltodextrin
	Comments	after treatment, 56 days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.715
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Energy Intake
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Baseline	873.16 (54.06)	867.61 (159.45)
56 days	760.19 (51.59)	725.34 (117.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oligofructose, Cellulose and Maltodextrin
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.578
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Oligofructose
	Comments	baseline to after treatment, at 56 days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cellulose and Maltodextrin
	Comments	baseline to after treatment, at 56 days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	calculated
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Gut Hormone PYY
Description	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)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber. Oligofructose: Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.	Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber. Placebo: 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
Measure Participants	0	0

6. Secondary Outcome

Title	Body Composition
Description	Body composition assessed by BMI
Time Frame	Baseline, 56 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Baseline	29.7 (1.0)	31.1 (1.1)
56 days	29.9 (1.1)	31.2 (1.1)

7. Secondary Outcome

Title	Imaging of Total Adipose Tissue
Description	Total adipose tissue was assessed by FMRI at baseline and after treatment period
Time Frame	Baseline, 56 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Baseline	36.3 (2.8)	38.4 (3.7)
56 days	37 (2.8)	38.7 (3.8)

8. Secondary Outcome

Title	Plasma Short-chain Fatty Acids Concentrations After Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Acetate	81.3 (2.1)	72.8 (1.8)
Propionate	5.4 (0.6)	5.4 (0.6)
Butyrate	0.9 (0.1)	0.7 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oligofructose, Cellulose and Maltodextrin
	Comments	Acetate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANCOVA
	Comments

9. Secondary Outcome

Title	Inflammatory Markers
Description	No data were collected for this Outcome Measure
Time Frame	baseline (Day 0) and post-supplementation (Day 56)

Outcome Measure Data

Analysis Population Description

Inflammatory markers where never measured for this study and so therefore no results available.

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	0	0

10. Secondary Outcome

Title	Glycemic Response
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Mean (95% Confidence Interval) [mmol/L]	4.8	4.7

11. Secondary Outcome

Title	Serum Insulin
Description	Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Time Frame	baseline (Day 0) and post-supplementation (Day 56)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	12	10
Mean (95% Confidence Interval) [(mU/L]	10.2	9.6

12. Secondary Outcome

Title	Breath Hydrogen Levels
Description	breath hydrogen were obtained from volunteers throughout the study session.
Time Frame	baseline (Day 0) and post-supplementation (Day 56)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Oligofructose	Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Measure Participants	0	0

Adverse Events

Time Frame	56 days
Arm/Group Title	Oligofructose		Cellulose and Maltodextrin
Arm/Group Description	Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.		Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
All Cause Mortality
	Oligofructose		Cellulose and Maltodextrin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Serious Adverse Events
	Oligofructose		Cellulose and Maltodextrin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Oligofructose		Cellulose and Maltodextrin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.