ObesityNCT03171948
Effects of a Limited Almond Consumption After a Weight Loss Plan on Weight Maintenance
A study testing Almond 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 this study is to assess the effects of limited portion of almond consumption after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight maintenance in obese female adults. 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 and Nut Free group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 10 Jun 2017to 17 Jan 2019
- 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
- female
- 18-45 years of age.
- Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
- Must be able to have moderate exercise.
- Must be interested to keep weight loss.
Who cannot join
- No Allergy to nut products
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
- Taking medications 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 a Limited Almond Consumption After a Successful Weight Loss by a Comprehensive Weight Loss Plan on Weight Maintenance in Healthy Obese Female Adults: a Randomised Clinical Trial
The purpose of this study is to assess the effects of limited portion of almond consumption after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight maintenance in obese female adults.
- Conditions
- Obesity, Overweight
- Being tested
- Almond Group, Nut Free group
- Keywords
- almond, weight loss, Weight maintenance, hypoenergetic diet
- 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 group
Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
Nut Free groupBehavioural
Also called NFG
continue their diet without any nut consumption.
| Study group | Role | What they receive |
|---|---|---|
| Almond group | Experimental | Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet Receives: Behavioral: Almond Group |
| Nut Free group | Experimental | Nut Free group (NFG), as control group, who continue their diet without any nut consumption. Receives: Behavioral: Nut Free group |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
kg
Measured: 6 Month
Secondary outcomes (7)
Waist circumference
cm
Measured: 6 Month
Fasting blood glucose
mmol/l
Measured: 6 Month
Fasting insulin level
mU/l
Measured: 6 Month
HbA1c
Measured: 6 Month
HOMA-IR
percentage (%)
Measured: 6 Month
lipid profiles
mmol/l
Measured: 6 Month
liver function
U/l
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start10 Jun 2017
- Primary completion12 Dec 2018
- Study completion17 Jan 2019
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
- Model description
- Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171948
- Sponsor's protocol ID
- ND-205
- Status last verified
- Jan 2019
- First submitted
- 27 May 2017
- Last updated
- 14 Mar 2019
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Limited Almond Consumption After a Successful Weight Loss by a Comprehensive Weight Loss Plan on Weight Maintenance in Healthy Obese Female Adults: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03171948
- Acronym / sponsor ID
- ND-205
- Conditions
- Obesity, Overweight
- Keywords
- almond, weight loss, Weight maintenance, hypoenergetic diet
- 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
- 10 Jun 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 31 May 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 this study is to assess the effects of limited portion of almond consumption after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight maintenance in obese female adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet Nut Free group (NFG), as control group, who continue their diet without any nut consumption.
| Arm | Type | Receives |
|---|---|---|
| Almond group | Experimental | Behavioral: Almond GroupAlmond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet |
| Nut Free group | Experimental | Behavioral: Nut Free groupNut Free group (NFG), as control group, who continue their diet without any nut consumption. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female
- 18-45 years of age.
- Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
- Must be able to have moderate exercise.
- Must be interested to keep weight loss.
Key exclusion criteria (7 listed)
- No Allergy to nut products
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
- Taking medications that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
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: AG groupAlmond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet | Behavioural | Almond group |
| Nut Free groupAlso: NFGcontinue their diet without any nut consumption. | Behavioural | Nut Free group |
Primary outcome
weight loss
Time frame: 6 Month
kg
7 secondary outcomes
Waist circumference
Time frame: 6 Month
Fasting blood glucose
Time frame: 6 Month
Fasting insulin level
Time frame: 6 Month
HbA1c
Time frame: 6 Month
HOMA-IR
Time frame: 6 Month
lipid profiles
Time frame: 6 Month
liver function
Time frame: 6 Month
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 14 Mar 2019.
- 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.
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 Almond 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 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 14 Mar 2019. 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. 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 loss (time frame: 6 Month). 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 14 Mar 2019.