ObesityNCT03120455
Effects of Almond Versus Pistachio on Weight Loss
A study testing Almond Group, Pistachio Group and Nut free group in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
Trial summary
The purpose of the current study is comparing the effect of almond and pistachio, as the two common types of nuts, consumption on healthy obese and overweight female who following a hypocaloric diet for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Almond Group, Pistachio Group and Nut free group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 5 Jun 2017to 15 Jan 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be female
- Must be 18-45 years of age.
- Must have Body mass index (BMI) between 27-35 kg/ m².
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Who cannot join
- Have allergy to nuts
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
- Menopause
- Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Almond Versus Pistachio on Weight Loss of Obese and Overweight Female Adults During Hypoenergetic Diet - a Randomized, 12 Week Clinical Trial
The purpose of the current study is comparing the effect of almond and pistachio, as the two common types of nuts, consumption on healthy obese and overweight female who following a hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these two type of nuts on other cardiometabolic risk factors.
- Conditions
- Obesity, Overweight
- Being tested
- Almond Group, Pistachio Group, Nut free group
- Keywords
- weight loss, Almond, Pistachio, hypoenergetic diet, Nut
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond GroupBehavioural
Also called AG
Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.
Pistachio GroupBehavioural
Also called PG
Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.
Nut free groupBehavioural
Also called NFG
Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.
| Study group | Role | What they receive |
|---|---|---|
| Almond group (AG) | Experimental | Obese or overweight female adults will be randomly allocated to have have almond as afternoon snack while they have a hypoenergetic diet. Receives: Behavioral: Almond Group |
| Pistachio group (PG) | Active comparator | Obese or overweight female adults will be randomly allocated to have have Pistachio as afternoon snack while they have a hypoenergetic diet. Receives: Behavioral: Pistachio Group |
| Nut Free (NFG, CG) | Placebo comparator | Obese or overweight female adults are asked to avoid all nuts, seeds, and nut products while they have a hypoenergetic diet. , as the control group. Receives: Behavioral: Nut free group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Body weight was taken to the nearest 0.1 kg using a digital calibrated scale (Omron Health Care, Hoofddorp, Netherland), whilst subjects wore light clothing and no shoes.
Measured: 12 Weeks
Secondary outcomes (7)
Waist circumference
Waist circumference (WC) was measured with a rigid measuring tape and recorded to the nearest 0.5 cm. WC was measured at the smallest horizontal circumference between the ribs and iliac crest (the natural waist), or, in case of an indeterminable waist narrowing, halfway between the lower rib and the iliac crest.
Measured: 12 Weeks
fasting blood glucose
Fasting plasma glucose (FPG) were measured using the enzymatic colorimetric method.
Measured: 12 Weeks
HbA1c
Glycated hamoglobin (HbA1c) was measured by a colorimetric method after an initial separation by ion exchange chromatography (Biosystem, Barcelona, Spain).
Measured: 12 Weeks
HOMA-IR
Insulin resistance was evaluated by homeostasis model assessment of insulin resistance (HOMA-IR), which was calculated by using the following formula HOMA-IR = [fasting insulin (mU/l) × FPG (mmol/l)]/22.5
Measured: 12 Weeks
lipid profiles
Biochemical analysis of the serum total cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) cholesterol was carried out on a Selectra E auto analyzer (Vita Laboratory, Netherlands) following standard procedures of the Pars Azmoon diagnostic kits (Iran). The LDL cholesterol was calculated using the Friedewald formula.
LDL cholesterol = TC - HDL cholesterol + (TG ÷ 2.2)
Measured: 12 Weeks
liver function tests
AST ALT
Measured: 12 Weeks
Insulin
Insulin was measured by using a radioimmunoassay with 125I-labeled human insulin and a human insulin antiserum in an immunoradiometric assay (IRMA) (Biosource, Dorest, Belgium) with a gamma-counter system (Gamma I; Genesys).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start5 Jun 2017
- Primary completion13 Nov 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Hamid R Farshchi, MD, PhD, Study chair, NovinDiet Clinic, School of Life Sciences, The University of NottinghamAmeneh Madjd, Dr, Principal investigator, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120455
- Sponsor's protocol ID
- ND-204
- Status last verified
- Mar 2018
- First submitted
- 15 Apr 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almond Versus Pistachio on Weight Loss of Obese and Overweight Female Adults During Hypoenergetic Diet - a Randomized, 12 Week Clinical Trial
- ClinicalTrials.gov ID
- NCT03120455
- Acronym / sponsor ID
- ND-204
- Conditions
- Obesity, Overweight
- Keywords
- weight loss, Almond, Pistachio, hypoenergetic diet, Nut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 19 Apr 2017 (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.
The purpose of the current study is comparing the effect of almond and pistachio, as the two common types of nuts, consumption on healthy obese and overweight female who following a hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these two type of nuts on other cardiometabolic risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Almond group (AG) | Experimental | Behavioral: Almond GroupObese or overweight female adults will be randomly allocated to have have almond as afternoon snack while they have a hypoenergetic diet. |
| Pistachio group (PG) | Active comparator | Behavioral: Pistachio GroupObese or overweight female adults will be randomly allocated to have have Pistachio as afternoon snack while they have a hypoenergetic diet. |
| Nut Free (NFG, CG) | Placebo comparator | Behavioral: Nut free groupObese or overweight female adults are asked to avoid all nuts, seeds, and nut products while they have a hypoenergetic diet. , as the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be female
- Must be 18-45 years of age.
- Must have Body mass index (BMI) between 27-35 kg/ m².
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Key exclusion criteria (8 listed)
- Have allergy to nuts
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
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 |
|---|---|---|
| Almond GroupAlso: AGObese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet. | Behavioural | Almond group (AG) |
| Pistachio GroupAlso: PGObese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet. | Behavioural | Pistachio group (PG) |
| Nut free groupAlso: NFGObese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet. | Behavioural | Nut Free (NFG, CG) |
Primary outcome
Weight
Time frame: 12 Weeks
Body weight was taken to the nearest 0.1 kg using a digital calibrated scale (Omron Health Care, Hoofddorp, Netherland), whilst subjects wore light clothing and no shoes.
7 secondary outcomes
Waist circumference
Time frame: 12 Weeks
fasting blood glucose
Time frame: 12 Weeks
HbA1c
Time frame: 12 Weeks
HOMA-IR
Time frame: 12 Weeks
lipid profiles
Time frame: 12 Weeks
liver function tests
Time frame: 12 Weeks
Insulin
Time frame: 12 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 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hamid R Farshchi, MD, PhD study chair
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Ameneh Madjd, Dr principal investigator
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
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 Group, Pistachio Group and Nut free group in people with Obesity and Overweight, run by Novindiet Clinic 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 5 inclusion and 8 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 29 Mar 2018. 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?
Weight (time frame: 12 Weeks). 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 29 Mar 2018.