Metabolic DisturbanceNCT06333184
Smoothies and Blood Sugars
A study testing Food in people with Metabolic Disturbance, run by University of Bath at 1 site in United Kingdom.
Trial summary
Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Body mass index 18-30 kg/m2
Who cannot join
- diagnosis of any form of diabetes
- intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
- Fructose malabsorption
- Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
- pregnant or lactating
- any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: Examining the Blood Sugar Response to Fruit Smoothie Consumption
Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.
- Conditions
- Metabolic Disturbance
- Being tested
- Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Fruit ingested in whole form or as either commercially available, or home-made smoothies
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 50 g glucose (55 g dextrose powder accounting for hydration) plus 417 mL water Receives: Other: Food |
| Product | Experimental | 417 mL of commercially available "Mango \& Passion fruit" fruit smoothie providing 50 g carbohydrate Receives: Other: Food |
| Whole | Experimental | Apples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as whole fruit with added water as needed to match volume. Receives: Other: Food |
| Blend | Experimental | Apples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as blended fruit with added water as needed to match volume. Receives: Other: Food |
| Slow | Experimental | 417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate ingested slowly over 25-35 mins. Receives: Other: Food |
| Fibre | Experimental | 417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate with 6 g of added inulin. Receives: Other: Food |
| Dose | Experimental | 250 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 30 g carbohydrate. Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index of product with capillary vs CGM
The difference in glycaemic index [2-hour incremental area under the curve (mmol/L-1x120 min) for PRODUCT relative to CONTROL expressed as a percentage] in capillary blood samples versus continuous glucose monitors.
Measured: 120 min
Secondary outcomes (1)
Glycaemic index of all conditions with capillary vs CGM
The difference in glycaemic index [2-hour incremental area under the curve (mmol/L-1x120 min) for all other conditions (WHOLE, BLEND, SLOW, FIBRE, DOSE) relative to CONTROL expressed as a percentage] in capillary blood samples versus continuous glucose monitors.
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start20 Mar 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333184
- Sponsor's protocol ID
- 3085-4215
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
Publications
Gonzalez JT. Are all sugars equal? Role of the food source in physiological responses to sugars with an emphasis on fruit and fruit juice. Eur J Nutr. 2024 Aug;63(5):1435-1451. doi: 10.1007/s00394-024-03365-3. Epub 2024 Mar 16.
PubMed 38492022Hutchins KM, Betts JA, Thompson D, Hengist A, Gonzalez JT. Continuous glucose monitor overestimates glycemia, with the magnitude of bias varying by postprandial test and individual - a randomized crossover trial. Am J Clin Nutr. 2025 May;121(5):1025-1034. doi: 10.1016/j.ajcnut.2025.02.024. Epub 2025 Feb 26.
PubMed 40021059
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Blood Sugar Response to Fruit Smoothie Consumption
- ClinicalTrials.gov ID
- NCT06333184
- Acronym / sponsor ID
- 3085-4215
- Conditions
- Metabolic Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Food50 g glucose (55 g dextrose powder accounting for hydration) plus 417 mL water |
| Product | Experimental | Other: Food417 mL of commercially available "Mango \& Passion fruit" fruit smoothie providing 50 g carbohydrate |
| Whole | Experimental | Other: FoodApples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as whole fruit with added water as needed to match volume. |
| Blend | Experimental | Other: FoodApples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as blended fruit with added water as needed to match volume. |
| Slow | Experimental | Other: Food417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate ingested slowly over 25-35 mins. |
| Fibre | Experimental | Other: Food417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate with 6 g of added inulin. |
| Dose | Experimental | Other: Food250 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 30 g carbohydrate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-65 years
- Body mass index 18-30 kg/m2
Key exclusion criteria (6 listed)
- diagnosis of any form of diabetes
- intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
- Fructose malabsorption
- Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
- pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodFruit ingested in whole form or as either commercially available, or home-made smoothies | Other | Blend, Control, Dose, Fibre, Product, Slow, Whole |
Primary outcome
Glycaemic index of product with capillary vs CGM
Time frame: 120 min
The difference in glycaemic index [2-hour incremental area under the curve (mmol/L-1x120 min) for PRODUCT relative to CONTROL expressed as a percentage] in capillary blood samples versus continuous glucose monitors.
1 secondary outcome
Glycaemic index of all conditions with capillary vs CGM
Time frame: 120 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 38492022Gonzalez JT. Are all sugars equal? Role of the food source in physiological responses to sugars with an emphasis on fruit and fruit juice. Eur J Nutr. 2024 Aug;63(5):1435-1451. doi: 10.1007/s00394-024-03365-3. Epub 2024 Mar 16.
- Derived from this study: PubMed 40021059Hutchins KM, Betts JA, Thompson D, Hengist A, Gonzalez JT. Continuous glucose monitor overestimates glycemia, with the magnitude of bias varying by postprandial test and individual - a randomized crossover trial. Am J Clin Nutr. 2025 May;121(5):1025-1034. doi: 10.1016/j.ajcnut.2025.02.024. Epub 2025 Feb 26.
- Individual participant dataSharing planned: Yes. De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Metabolic Disturbance, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic index of product with capillary vs CGM (time frame: 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.