PreDiabetesNCT05322304
Almonds and Cognitive Functions
A study testing Almond in people with PreDiabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
Initial Recruitment and Sensitization: In this free-living randomized control parallel arm study of 24 weeks of almond intervention, we shall recruit apparently healthy middle aged (age range 40-60 years)prediabetic Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Almond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2022to 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose)
- age 40-60 years
Who cannot join
- Subjects Having Inability to Undergo Neuropsychological Testing
- Previously Diagnosed Neurodegenerative Disease Prior Stroke
- Significant Head Trauma, or Brain Surgery
- Relevant Psychiatric Illness
- Major Depression
- Morbid Obesity
Show all 14Show fewer
- Diabetes
- Uncontrolled Hypertension
- Prior Chemotherapy
- Allergy to Almonds
- Habitual Consumption of Tree nuts (>2 Servings/Wk.); or Customary Use Of Fish Oil, Flaxseed Oil, and/ Or Soy Lecithin
- Chronic Smoking
- Alcohol abuse (> 2 Drinks, 60 Ml Of Whisky Per Day)
- Severe Dyslipidemia (Total Cholesterol > 300 Mg/Dl, Serum Triglycerides > 500mg/Dl)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
National Diabetes Obesity and cholesterol Foundation (NDOC)
Delhi, 110024
Seema Gulati, Ph.D, 09312069151, seemagulati2007@gmail.com
Anoop Misra, 41759672, anoopmisra@gmail.com
About this study
Official title: Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
Initial Recruitment and Sensitization: In this free-living randomized control parallel arm study of 24 weeks of almond intervention, we shall recruit apparently healthy middle aged (age range 40-60 years)prediabetic Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose).
Read the detailed description
Objectives and Measurements:
- Primary Objective: To evaluate the effect of almond supplementation on cognitive functions Co-primary Objective: To evaluate changes in neuroimaging (blood flow, and the expression of functional brain networks during cognitive demands) using functional MRI.
Flow of Study Procedures
- This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria.
- Sample size: 60 (n, 30 in each arm)
- After recruitment subjects would enter the run-in period for 2 weeks when they would be given standard diet and lifestyle modification counseling formulated according to guidelines for Asian Indians.
- Subjects would be screened again just for inclusion/exclusion criteria at the end of the run-in period and would be randomized either to the experimental group or control group
- Composition of diets:
- Intervention group: Individualized diets incorporating almonds, 20% energy. Macronutrient composition: Carbohydrates,49%en., fats,32%en., and proteins, 19%en. ii. Control group: Isocaloric diet. Macronutrient composition: Carbohydrates,50%en., fats, 35%en., proteins,15%en.
- The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance
- Compliance Checks: The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance check .
Compliance for the intervention in all the subjects (control and intervention group) will be checked by taking following measures:
- Biweekly telephonic calls. During these telephonic calls compliance to diet, exercise, almond intake, adverse event or any problem with the intervention will be assessed. Calls will be recorded in a call log and subject compliance (consumption of almonds) will be recorded in the proforma.
- Text messages reminding intake of almonds (weekly) and face-to-face interactions (once every month, at least 20 min each session) discussing problems if any.
- Conditions
- PreDiabetes
- Being tested
- Almond
- Keywords
- almonds, prediabetes, cognition
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondDietary supplement
Intervention (almond supplementation) and Isocaloric diets (control)
| Study group | Role | What they receive |
|---|---|---|
| almond | Experimental | dietary intervention with almonds ()20% of energy) Receives: Dietary Supplement: Almond |
| Control | No intervention | usual diet and lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological function
cognitive functions using computerized neuropsychological assessment systems (CANTAB
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jun 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel arm randomized controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation, Almond Board of California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322304
- Sponsor's protocol ID
- NDOC.12/2022
- Status last verified
- Feb 2023
- First submitted
- 25 Mar 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gulati S, Misra A, Tiwari R, Pandey RM, Sharma M. Effects of 24-Week Almond Supplementation on Executive Function and Processing Speed in Middle-Aged Asian Indians with Prediabetes: An Open-Label Randomized Controlled Trial. J Nutr. 2026 May;156(5):101484. doi: 10.1016/j.tjnut.2026.101484. Epub 2026 Mar 16.
PubMed 41850683
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
- ClinicalTrials.gov ID
- NCT05322304
- Acronym / sponsor ID
- NDOC.12/2022
- Conditions
- PreDiabetes
- Keywords
- almonds, prediabetes, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation, Almond Board of California
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 11 Apr 2022 (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.
Initial Recruitment and Sensitization: In this free-living randomized control parallel arm study of 24 weeks of almond intervention, we shall recruit apparently healthy middle aged (age range 40-60 years)prediabetic Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose).
Detailed description
Objectives and Measurements:
- Primary Objective: To evaluate the effect of almond supplementation on cognitive functions Co-primary Objective: To evaluate changes in neuroimaging (blood flow, and the expression of functional brain networks during cognitive demands) using functional MRI.
Flow of Study Procedures
- This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria.
- Sample size: 60 (n, 30 in each arm)
- After recruitment subjects would enter the run-in period for 2 weeks when they would be given standard diet and lifestyle modification counseling formulated according to guidelines for Asian Indians.
- Subjects would be screened again just for inclusion/exclusion criteria at the end of the run-in period and would be randomized either to the experimental group or control group
- Composition of diets:
- Intervention group: Individualized diets incorporating almonds, 20% energy. Macronutrient composition: Carbohydrates,49%en., fats,32%en., and proteins, 19%en. ii. Control group: Isocaloric diet. Macronutrient composition: Carbohydrates,50%en., fats, 35%en., proteins,15%en.
- The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance
- Compliance Checks: The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance check .
Compliance for the intervention in all the subjects (control and intervention group) will be checked by taking following measures:
- Biweekly telephonic calls. During these telephonic calls compliance to diet, exercise, almond intake, adverse event or any problem with the intervention will be assessed. Calls will be recorded in a call log and subject compliance (consumption of almonds) will be recorded in the proforma.
- Text messages reminding intake of almonds (weekly) and face-to-face interactions (once every month, at least 20 min each session) discussing problems if any.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel arm randomized controlled
| Arm | Type | Receives |
|---|---|---|
| almond | Experimental | Dietary Supplement: Almonddietary intervention with almonds ()20% of energy) |
| Control | No intervention | –usual diet and lifestyle |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose)
- age 40-60 years
Key exclusion criteria (14 listed)
- Subjects Having Inability to Undergo Neuropsychological Testing
- Previously Diagnosed Neurodegenerative Disease Prior Stroke
- Significant Head Trauma, or Brain Surgery
- Relevant Psychiatric Illness
- Major Depression
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 |
|---|---|---|
| AlmondIntervention (almond supplementation) and Isocaloric diets (control) | Dietary supplement | almond |
Primary outcome
neuropsychological function
Time frame: 2 year
cognitive functions using computerized neuropsychological assessment systems (CANTAB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 41850683Gulati S, Misra A, Tiwari R, Pandey RM, Sharma M. Effects of 24-Week Almond Supplementation on Executive Function and Processing Speed in Middle-Aged Asian Indians with Prediabetes: An Open-Label Randomized Controlled Trial. J Nutr. 2026 May;156(5):101484. doi: 10.1016/j.tjnut.2026.101484. Epub 2026 Mar 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond in people with PreDiabetes, run by Diabetes Foundation, India at 1 site in India.
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 14 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (011-41759672 ext. 103, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychological function (time frame: 2 year). 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 NCT05322304, which also lists 1 linked publication.
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 16 Feb 2023.