Type2diabetesNCT07863934
Effects of High-Intensity Interval Training and Quinoa Supplementation in Women With Type 2 Diabetes
A study testing High-intensity interval training, Daily quinoa and Combined high-intensity interval training and quinoa consumption in people with Type2diabetes, run by University of Central Lancashire at 1 site in Iran.
Trial summary
This study evaluated the effects of eight weeks of high-intensity interval training (HIIT), daily quinoa consumption, and their combination on inflammatory markers and blood glucose control in women aged 50-65 years with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Type2diabetes
- What is being tested?
- High-intensity interval training, Daily quinoa and Combined high-intensity interval training and quinoa consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- 16 Oct 2024to 28 Dec 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 50-65 years of age
- Diagnosed with type 2 diabetes for at least 5 years
- Fasting blood glucose >126 mg/dL OR HbA1c ≥6.5%
- Receiving metformin therapy
- Able to participate safely in the exercise intervention
- Able and willing to provide written informed consent
Who cannot join
- Current insulin therapy
- Diagnosed cardiovascular disease
- Thyroid disorders
- Diabetic foot ulcers
- Recent hospitalization
- Regular participation in a structured exercise programme
- Exercise intolerance, specifically manifested by: discomfort, severe fatigue, imbalance or dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-Intensity Interval Training and Quinoa Supplementation on Some Selected Pyroptosis Proteins and Glycemic Control in Women With Type 2 Diabetes: A Randomized Controlled Trial.
This study evaluated the effects of eight weeks of high-intensity interval training (HIIT), daily quinoa consumption, and their combination on inflammatory markers and blood glucose control in women aged 50-65 years with type 2 diabetes. Participants were randomly assigned to four groups: HIIT, quinoa consumption, combined HIIT and quinoa consumption, or control. The quinoa groups consumed 25 g of cooked quinoa daily for eight weeks. Blood markers and body measurements were assessed before and after the intervention.
- Conditions
- Type2diabetes
- Being tested
- High-intensity interval training, Daily quinoa, Combined high-intensity interval training and quinoa consumption, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Supervised HIIT three times per week for 8 weeks (24 sessions). Each repetition consisted of a 40 m shuttle run (10 m + 20 m + 10 m), followed by 30 seconds of active recovery. Training progressed from 4 repetitions in weeks 1-2, 5 in weeks 3-4, 6 in weeks 5-6, and 8 in weeks 7-8, performed at 85-90% of age-predicted maximum heart rate.
Daily quinoaDietary supplement
25 g/day of cooked quinoa seeds as a morning snack between 10:00 and 11:00 AM, every day for 8 weeks.
Combined high-intensity interval training and quinoa consumptionCombination product
Participants completed the same 8-week HIIT programme and simultaneously consumed 25 g/day of cooked quinoa using the same supplementation schedule.
ControlOther
Participants received no HIIT and no quinoa supplementation. They were instructed to maintain their usual diet, medication use and habitual physical activity, and not to begin any new exercise, dietary or supplementation programme during the 8-week trial.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Not described Receives: Behavioral: High-intensity interval training |
| Daily quinoa | Experimental | Not described Receives: Dietary Supplement: Daily quinoa |
| Combined high-intensity interval training and quinoa consumption | Experimental | Not described Receives: Combination Product: Combined high-intensity interval training and quinoa consumption |
| Control | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
NLRP3
A circulating marker of inflammasome activation/pyroptosis, measured in fasting serum using an ELISA assay.
Measured: Baseline
NLRP3
A circulating marker of inflammasome activation/pyroptosis, measured in fasting serum using an ELISA assay.
Measured: 8-weeks
Secondary outcomes (14)
IL-18
A pro-inflammatory cytokine associated with inflammasome activity, measured in fasting serum using an ELISA assay.
Measured: Baseline
IL-18
A pro-inflammatory cytokine associated with inflammasome activity, measured in fasting serum using an ELISA assay.
Measured: 8-weeks
HbA1c
A marker of average blood glucose control over the preceding several months, measured using capillary electrophoresis.
Measured: Baseline
HbA1c
A marker of average blood glucose control over the preceding several months, measured using capillary electrophoresis.
Measured: 8-weeks
Fasting blood glucose
The concentration of glucose in the blood following an overnight fast, measured using a photometric assay.
Measured: Baseline
Fasting blood glucose
The concentration of glucose in the blood following an overnight fast, measured using a photometric assay.
Measured: 8-weeks
Fasting insulin
The concentration of circulating insulin under fasting conditions, measured using electrochemiluminescence.
Measured: Baseline
Fasting insulin
The concentration of circulating insulin under fasting conditions, measured using electrochemiluminescence.
Measured: 8-weeks
HOMA-IR
An estimate of insulin resistance, calculated from fasting insulin and fasting glucose using [insulin × glucose]/405.
Measured: Baseline
HOMA-IR
An estimate of insulin resistance, calculated from fasting insulin and fasting glucose using [insulin × glucose]/405.
Measured: 8-weeks
Body weight
Total body mass measured in kilograms using standardised weighing equipment, with participants in light clothing and without shoes.
Measured: Baseline
Body weight
Total body mass measured in kilograms using standardised weighing equipment, with participants in light clothing and without shoes.
Measured: 8-weeks
Body mass index
Body mass relative to height, calculated as body weight (kg) divided by height squared (m²).
Measured: Baseline
Body mass index
Body mass relative to height, calculated as body weight (kg) divided by height squared (m²).
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start16 Oct 2024
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- Allameh Tabataba'i University
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863934
- Sponsor's protocol ID
- High-Intensity and Quinoa
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training and Quinoa Supplementation on Some Selected Pyroptosis Proteins and Glycemic Control in Women With Type 2 Diabetes: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07863934
- Acronym / sponsor ID
- High-Intensity and Quinoa
- Conditions
- Type2diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- Allameh Tabataba'i University
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 7 Oct 2026 (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.
This study evaluated the effects of eight weeks of high-intensity interval training (HIIT), daily quinoa consumption, and their combination on inflammatory markers and blood glucose control in women aged 50-65 years with type 2 diabetes. Participants were randomly assigned to four groups: HIIT, quinoa consumption, combined HIIT and quinoa consumption, or control. The quinoa groups consumed 25 g of cooked quinoa daily for eight weeks. Blood markers and body measurements were assessed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity interval training |
| Daily quinoa | Experimental | Dietary Supplement: Daily quinoa |
| Combined high-intensity interval training and quinoa consumption | Experimental | Combination Product: Combined high-intensity interval training and quinoa consumption |
| Control | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- 50-65 years of age
- Diagnosed with type 2 diabetes for at least 5 years
- Fasting blood glucose >126 mg/dL OR HbA1c ≥6.5%
- Receiving metformin therapy
Key exclusion criteria (7 listed)
- Current insulin therapy
- Diagnosed cardiovascular disease
- Thyroid disorders
- Diabetic foot ulcers
- Recent hospitalization
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 |
|---|---|---|
| High-intensity interval trainingSupervised HIIT three times per week for 8 weeks (24 sessions). Each repetition consisted of a 40 m shuttle run (10 m + 20 m + 10 m), followed by 30 seconds of active recovery. Training progressed from 4 repetitions in weeks 1-2, 5 in weeks 3-4, 6 in weeks 5-6, and 8 in weeks 7-8, performed at 85-90% of age-predicted maximum heart rate. | Behavioural | High-intensity interval training |
| Daily quinoa25 g/day of cooked quinoa seeds as a morning snack between 10:00 and 11:00 AM, every day for 8 weeks. | Dietary supplement | Daily quinoa |
| Combined high-intensity interval training and quinoa consumptionParticipants completed the same 8-week HIIT programme and simultaneously consumed 25 g/day of cooked quinoa using the same supplementation schedule. | Combination product | Combined high-intensity interval training and quinoa consumption |
| ControlParticipants received no HIIT and no quinoa supplementation. They were instructed to maintain their usual diet, medication use and habitual physical activity, and not to begin any new exercise, dietary or supplementation programme during the 8-week trial. | Other | Control |
Primary outcome
NLRP3
Time frame: Baseline
A circulating marker of inflammasome activation/pyroptosis, measured in fasting serum using an ELISA assay.
NLRP3
Time frame: 8-weeks
A circulating marker of inflammasome activation/pyroptosis, measured in fasting serum using an ELISA assay.
14 secondary outcomes
IL-18
Time frame: Baseline
IL-18
Time frame: 8-weeks
HbA1c
Time frame: Baseline
HbA1c
Time frame: 8-weeks
Fasting blood glucose
Time frame: Baseline
Fasting blood glucose
Time frame: 8-weeks
Fasting insulin
Time frame: Baseline
Fasting insulin
Time frame: 8-weeks
HOMA-IR
Time frame: Baseline
HOMA-IR
Time frame: 8-weeks
Body weight
Time frame: Baseline
Body weight
Time frame: 8-weeks
Body mass index
Time frame: Baseline
Body mass index
Time frame: 8-weeks
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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 High-intensity interval training, Daily quinoa and Combined high-intensity interval training and quinoa consumption in people with Type2diabetes, run by University of Central Lancashire at 1 site in Iran.
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 7 inclusion and 7 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 7 Oct 2026. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
NLRP3 (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.