NCT03171948

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

June 10, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

March 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

May 27, 2017

Last Update Submit

March 13, 2019

Conditions

ObesityOverweight

Keywords

almondweight lossWeight maintenancehypoenergetic diet

Outcome Measures

Primary Outcomes (1)

  • weight loss

    kg

    6 Month

Secondary Outcomes (7)

  • Waist circumference

    6 Month

  • Fasting blood glucose

    6 Month

  • Fasting insulin level

    6 Month

  • HbA1c

    6 Month

  • HOMA-IR

    6 Month

  • +2 more secondary outcomes

Study Arms (2)

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

Behavioral: Almond Group

Nut Free group

EXPERIMENTAL

Nut Free group (NFG), as control group, who continue their diet without any nut consumption.

Behavioral: Nut Free group

Interventions

Almond GroupBEHAVIORAL

Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet

Also known as: AG group
Almond group
Nut Free groupBEHAVIORAL

continue their diet without any nut consumption.

Also known as: NFG
Nut Free group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, Iran

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

SEMA7A protein, human

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

June 10, 2017

Primary Completion

December 12, 2018

Study Completion

January 17, 2019

Last Updated

March 14, 2019

Record last verified: 2019-01

Locations

IR(1)