NCT04695418

Brief Summary

Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p\<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 28, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

December 29, 2020

Last Update Submit

January 4, 2021

Conditions

Obesity

Keywords

Rice GermBody compositionAmino acids

Outcome Measures

Primary Outcomes (1)

  • Change of body composition

    free fat mass (g), fat mass (g), visceral abdominal tissue (g)

    Baseline and 4 weeks

Secondary Outcomes (14)

  • Change of amino acid profiles

    Baseline and 4 weeks

  • Change of biochemical metabolic parameters

    Baseline and 4 weeks

  • Change of biochemical metabolic parameters

    Baseline and 4 weeks

  • Change of biochemical metabolic parameters

    Baseline and 4 weeks

  • Change of biochemical metabolic parameters

    Baseline and 4 weeks

  • +9 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

an isocaloric wheat germ-based supplement

Combination Product: Placebo

Rice Germ

ACTIVE COMPARATOR
Dietary Supplement: Rice Germ

Interventions

Rice GermDIETARY_SUPPLEMENT

The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks

Rice Germ
PlaceboCOMBINATION_PRODUCT

An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks

Placebo

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obesity (BMI 30-40 kg/m2)
  • age 50-65
  • menopause
  • sedentary women and non-smoking,
  • women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
  • women who agreed not to take part in any other weight loss program

You may not qualify if:

  • evidence of heart, kidney or liver disease
  • women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
  • taking any medications for weight loss
  • control of cholesterol and triglycerides for anti-inflammatory purposes
  • pregnancy
  • lactating
  • Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
  • antibiotic use in the last three months
  • probiotic/prebiotic treatment in the last four weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2020

First Posted

January 5, 2021

Study Start

January 28, 2018

Primary Completion

December 2, 2019

Study Completion

December 27, 2019

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)